Baxter acquires surgical products

Baxter International Inc., a global medical products company, said Monday that it will acquire two hemostat and sealant products from Mallinckrodt.

It will acquire Recothrom Thrombin topical, the first and only stand-alone recombinant thrombin, and Preveleak Surgical Sealant, which is used in vascular reconstruction.

"Uncontrolled intraoperative bleeding can lead to a wide variety of clinical and economic complications for patients and hospitals. As a leading provider of advanced hemostats and sealants, Deerfield-based Baxter is focused on continually identifying solutions to help meet surgeons' varying needs," said Wil Boren, president of Baxter's Advanced Surgery business. "We are excited about the addition of Recothrom to help surgeons address less severe intraoperative bleeding and Preveleak to complement Baxter's existing portfolio of sealants for cardiovascular and other surgical specialties."

Thrombin is a proven blood coagulation agent -- used on its own or in combination with other hemostats -- that has been estimated to be used in more than one million patients per year in the United States to help surgeons address intraoperative bleeding.

Recothrom is a thrombin-based product indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. As the only topical hemostat from recombinant DNA origin approved in the United States and Canada, Recothrom can be used in pediatric and adult patients with or without antibodies to bovine-derived thrombin.

The acquisition also includes Preveleak, a surgical sealant designed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured connections between blood vessels. Preveleak augments Baxter's portfolio of complementary hemostats, sealants and tissue products used in cardiovascular and other surgeries, offering surgeons additional clinically differentiated products to address patients' varying needs. Preveleak is approved in the United States and European Union.

Sales of the proposed acquired products totaled approximately $56 million in the twelve months preceding Sept. 29. Upon closing, the deal is expected to be modestly accretive to Baxter's 2018 adjusted earnings and increasingly accretive thereafter. Under the terms of the agreement, Baxter will acquire Recothrom and Preveleak for an upfront payment of approximately $153 million and potential contingent payments in the future.

The transaction is expected to close in the first half of 2018, subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

Mallinckrodt Diversifies Hospital Growth Portfolio, Acquiring Three Commercial-Stage, Global Specialty Hemostasis Brands From The Medicines Company

CHESTERFIELD, United Kingdom, Dec. 18, 2015 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced that it has entered into a purchase agreement with The Medicines Company (NASDAQ: MDCO) under which subsidiaries of Mallinckrodt plc will acquire a global portfolio of three commercial-stage topical hemostasis drugs – RECOTHROM® Thrombin topical (Recombinant), PreveLeak™ Surgical Sealant, and RAPLIXA™ (Fibrin Sealant) – for an initial payment of approximately $175 million, inclusive of existing inventory. The transaction also includes potential added future considerations in the form of payments for achieving certain milestones, and is expected to be financed from cash on hand.

"Addition of this innovative portfolio of branded hemostats to our hospital platform is another demonstration of Mallinckrodt's 'acquire to invest' business strategy. Products that help control bleeding are essential to the vast majority of surgical practices. Yet this category – a market that has been estimated at $750 million in the U.S. and at least $1 billion globally – is an area in hospital products that has seen relatively little innovation and investment in recent years," said Mark Trudeau, Chief Executive Officer and President of Mallinckrodt.

Trudeau continued, "Acquiring and promoting leading hemostasis brand RECOTHROM alongside OFIRMEV® (acetaminophen) injection broadens Mallinckrodt's impact in the surgical suite for patients and physicians, and creates a strong framework to broadly commercialize innovative, highly durable new agents PreveLeak and RAPLIXA, which carry intellectual property protection to 2028 and 2031, respectively. As we continue to further diversify our portfolio, we're excited about the volume growth opportunity these products will add to our hospital offering for years to come."

On a reported U.S. GAAP1 basis, Mallinckrodt expects the transaction to be dilutive to its fiscal 2016 earnings per share (EPS); however, on an adjusted basis, the company expects the transaction to be neutral to EPS in fiscal 2016. On both a U.S. GAAP and adjusted basis, the company expects the transaction to be accretive to EPS beginning in fiscal 2017. Assuming a closing in the second quarter of fiscal 2016, the company expects the new products will add between $40 million and $45 million in incremental revenue in fiscal 2016, and provide low double-digit organic growth starting in fiscal 2017.

Through this acquisition, the company is expected to capitalize on synergies with Mallinckrodt's current U.S. commercial team focused on pain management in hospital surgical practice with OFIRMEV, the company's intravenous acetaminophen product indicated for the management of mild to moderate pain, and management of moderate to severe pain with adjunctive opioid analgesics. With expanded product offerings including OFIRMEV, RECOTHROM, PreveLeak and RAPLIXA, and with focused promotion, the company's commercial organization – supported by Mallinckrodt's strong sales, market access, national accounts and medical affairs teams – is expected to broaden access for patients who would benefit from these analgesic and hemostasis drugs.

Hemostasis Products

Each of the three drugs being acquired is approved by the U.S. Food and Drug Administration (FDA) and also in a number of other countries.

Introduced in 2009, RECOTHROM is widely used in the U.S., and is the first and only recombinant topical thrombin approved for use in adult and pediatric patients. It is FDA-approved as a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM is also marketed internationally through distributors.

Upon closing, Mallinckrodt will invest in the commercial launch and ongoing market development of both PreveLeak and RAPLIXA in fiscal year 2016. Both have shorter preparation times and are easier to use and store than similar products in their categories. PreveLeak is more flexible than hemostasis glue products, is a surgical sealant and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. PreveLeak is currently marketed in Europe through distributors. 

RAPLIXA is the first and only powder fibrin sealant in ready-to-use room temperature form, with the RAPLIXASpray™ device allowing for even application over a diffuse bleeding site and greater versatility. RAPLIXA is comprised of human-plasma derived fibrinogen and thrombin and FDA-approved as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and is applied directly or by using the RAPLIXASpray device.

FDA Accepts Biologic License Application for Fibrocaps Hemostatic Agent

The Medicines Company has announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. The FDA action date (PDUFA date) for Fibrocaps is January 31, 2015. 

In August 2013, The Medicines Company announced that the Phase III trial, FINISH-3, which studied a total of 719 patients across 54 sites in the U.S. and Western Europe, met all of its primary and secondary hemostasis efficacy endpoints in each of four distinct populations: (1) spinal surgery; (2) hepatic resection; (3) soft tissue dissection; and (4) vascular surgery. 

"We believe Fibrocaps has the potential to become an important hemostatic product -- complementary to Recothrom® Thrombin, topical (Recombinant) -- which will allow us to continue to serve leading US hospitals, leveraging our existing operations. Our previously announced EMA filing also suggests that Fibrocaps can be our first hemostat product in the European market," said Adam Sharkawy, PhD, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company. 

"With the acceptance of the Fibrocaps BLA we now have 6 new molecular entity regulatory submissions under review at the FDA and the EMA," said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. "These applications span our three areas of focus in leading hospitals, namely: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. Each is designed to contribute to our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on the needs of leading hospitals worldwide."

Medicines Co. wraps $240M deal to buy ProFibrix following PhIII success

The Medicines Company has swooped in to buy out the Dutch biotech ProFibrix, chipping in $90 million in cash on top of a $10 million option anted up in June as Phase III data on a lead surgical therapy loomed. And the buyer has agreed to pay up to $140 million more for a set of unspecified milestones.

The Medicines Company ($MDCO) is landing Fibrocaps in the deal, an easy-to-use dry-powder formulation of fibrinogen and thrombin that can be used to stop bleeding during surgery, a process referred to as hemostasis. In their release today the companies noted that the lead biologic hit all primary and secondary endpoints on four surgical indications: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. Investigators recruited 719 patients for the Phase III study.

The plan now is to file for EU approval in the fourth quarter of this year, with an FDA application following in the first quarter of 2014, commented ProFibrix CEO Jan Ohrstrom. And The Medicines Company believes it can earn more than $300 million a year on the product, provided it wins key approvals.

"The company was founded in 2007 with an A round from Index Ventures," adds Ohrstrom. Phase I was run in 2008 and investigators are now wrapping a 5-year clinical program, with more work scheduled on laparoscopic surgery as well as a pediatric program. The CEO says more indications are also being "toyed with," but he declined to elaborate. The company's lab in Leiden will stay operational, says Ohrstrom, the former chief medical officer of ZymoGenetics. ProFibrix currently has 25 employees in Leiden and Seattle, where it has a clinical development site.

"Subject to regulatory approval, we believe Fibrocaps can become an important hemostatic product--complementary to Recothrom (Thrombin, topical [Recombinant])," says Clive Meanwell, the CEO at The Medicines Co. "We anticipate leverage of our work with U.S. surgery centers and entry into the European market. … ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products. We plan to integrate the ProFibrix team with our existing Recothrom team--expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."

The market for hemostatic products has been busy with new developments for years. Just a few weeks ago Omrix Biopharmaceuticals won a recommendation from the CHMP in Europe for the sealant matrix Evarrest, which also combines fibrinogen and thrombin. But The Medicines Company is hoping that ProFibrix's off-the-shelf technology will quickly win converts.

RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in Children Greater Than or Equal to One Month of Age

PARSIPPANY, NJ--(Marketwired - May 9, 2013) -  The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for RECOTHROM®, Thrombin topical (Recombinant) to include use in pediatric patients, following completion of a post-approval pediatric clinical trial commitment. RECOTHROM is a recombinant topical thrombin now indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adult and pediatric populations greater than or equal to one month of age. RECOTHROM provides patients greater than one month of age an alternative to bovine or human plasma derived thrombin. 

"Pediatric patients, in various surgical settings, have an increased chance of repeat surgeries. RECOTHROM has been studied in pediatric patients and shown to have a low rate of immunogenicity, and offers an important tool for use in this patient population," said Kevin N. Foster, MD, MBA, FACS, Chief, Burn Services, The Arizona Burn Center at Maricopa Medical Center.

The recent FDA approval is based, in part, on data from a completed Phase 4, open-label, single-group safety and immunogenicity study. This study was conducted in 30 pediatric patients greater than one month of age undergoing synchronous burn wound excision and skin grafting. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults. Safety and efficacy has not been established in neonates.

"Our purpose is to save lives, alleviate suffering and improve the economic efficiency of the approximately 2,500 leading hospitals in the world," said Brent Furse, Senior Vice President and Chief Customer Officer of The Medicines Company. "There are several hundred leading hospitals in the United States that conduct thousands of surgical procedures in pediatric patients each year. We believe the expanded pediatric indication for RECOTHROM provides an opportunity to make this topical hemostat available to a broader range of surgical patients."

About The Medicines CompanyThe Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.

MDCO, Bristol-Myers Squibb begin global alliance for Recothrom

The global license and two-year collaboration signed between the Medicines Company (MDCO) and Bristol-Myers Squibb (BMS) for Recothrom, a recombinant thrombin approved by the US Food and Drug Administration (FDA) for use as a topical hemostat to control non-arterial bleeding during surgical procedures has become effective. The agreement was first announced in December 2012. The companies have satisfied all required regulatory and closing conditions. Glenn Sblendorio, president and chief financial officer of The Medicines Company, said, "We look forward to the start of our global license and collaboration for Recothrom. We believe that completing this deal is another step to establish The Medicines Company as a leader in acute and intensive care medicine globally." Recothrom is a surgical hemostat that is applied topically to stop bleeding during surgery. Its active ingredient is recombinant human thrombin (rThrombin) and the product is indicated as an aid to hemostasis whenever control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. Recothrom is part of a class of surgical hemostats commonly referred to as "active" hemostats. Other classes of surgical hemostats include mechanical hemostats, flowable hemostats and fibrin sealants. Recothrom was approved in the United States in January 2008 and in Canada in December 2010. The Medicines Company provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide.

The Medicines Company and Bristol-Myers Squibb Agree to Global Alliance For Recothrom

The Medicines Company builds on portfolio and capabilities in acute and intensive care hospital medicine with marketed perioperative biologic

Parsippany, NJ, and Princeton, NJ, USA I December 12, 2012 I The Medicines Company (NASDAQ:MDCO) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have signed a global license and two year collaboration for Recothrom®, a recombinant thrombin approved by the U.S. Food and Drug Administration for use as a topical hemostat to control non-arterial bleeding during surgical procedures.

Clive Meanwell, M.D., Ph.D., Chairman and CEO of The Medicines Company said, “As a marketed, growing product to control blood loss in the hospital, we believe Recothrom is a strategic fit that enables operating leverage with The Medicines Company’s emerging perioperative care portfolio. The financial structures and net revenues fit well with our strategy for aggressive and sustainable growth in acute and intensive care medicine. Of course, thrombin is also a hemodynamic target we know well based on our experience with Angiomax® (bivalirudin), a thrombin inhibitor.”

“The Medicines Company’s expertise in advancing the treatment of critical care patients in hospital settings worldwide makes it the natural partner to bring Recothrom to patients and physicians,” said Giovanni Caforio, President, U.S. Pharmaceuticals of Bristol-Myers Squibb. “This agreement is part of Bristol-Myers Squibb’s ongoing efforts to simplify operations, improve our efficiency and better position ourselves to focus on our important work in areas of significant unmet medical need that are critical to our long-term success."

Recothrom net revenues in 2011 were $65 million. The product is currently commercially available in the United States and Canada. The intellectual property license agreement is global and The Medicines Company anticipates pursuing approvals in additional countries.

The transaction is expected to be accretive to earnings per share (EPS) for The Medicines Company in 2013.

Under terms of the agreement, The Medicines Company will pay Bristol-Myers Squibb an upfront collaboration payment of $105 million and an upfront option fee of $10 million. The Medicines Company has also agreed to pay Bristol-Myers Squibb a tiered royalty on annual net revenues of Recothrom during the two-year collaboration term. Bristol-Myers Squibb will retain responsibility for the manufacturing of Recothrom and will be The Medicine Company’s exclusive supplier of Recothrom during the term of the agreement. The option enables The Medicines Company to acquire the Recothrom assets for a purchase price based on average net sales during the two-year collaboration term.

The transaction is expected to be minimally accretive to EPS for Bristol-Myers Squibb in 2013 and 2014.

The transaction is subject to the satisfaction or waiver of closing conditions, including the expiration or termination of applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the delivery by Bristol-Myers Squibb of certain audited financial information relating to the business.

King Pharma Disappoints

King Pharma's branded Pharmaceuticals segment declined 43.3% with revenues coming in at $160.8 million. Revenues of almost all key products declined from the year-ago period.
Thrombin-JMI sales declined 25.9% to $32.2 million. We expect Thrombin-JMI sales to continue declining due to tough competition in the form of Bristol-Myers Squibbs’ Recothrom and Johnson & Johnson’s Evithrom.

Bristol-Myers Squibb to Acquire ZymoGenetics

BMS to Pick Up ZymoGenetics for $885M
NEW YORK & SEATTLE, Sep 07, 2010 (BUSINESS WIRE) -- --Gains Full Rights to Promising Phase II Hepatitis C Biologic, Pegylated-Interferon Lambda

--Obtains FDA-Approved Specialty Surgical Biologic, RECOTHROM(R)

--Attains Early Clinical and Pre-clinical Programs in Oncology and Immunoscience

Bristol-Myers Squibb Company (BMY 26.78, +0.17, +0.64%) and ZymoGenetics, Inc.(ZGEN 9.76, +4.46, +84.06%) announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash. The transaction, with an aggregate purchase price of approximately $885 million, or approximately $735 million net of cash acquired, has been unanimously approved by the boards of directors of both companies. The board of directors of ZymoGenetics intends to recommend that ZymoGenetics' shareholders tender their shares in the tender offer. In addition, shareholders holding approximately 37% of the outstanding shares of ZymoGenetics' common stock have entered into agreements with Bristol-Myers Squibb to support the transaction and to tender their shares in the offer.

"The acquisition of ZymoGenetics brings us full ownership of a promising investigational biologic that strengthens our very diversified Hepatitis C portfolio. Building on our leadership in virology, we are developing a strong portfolio to help patients with Hepatitis C," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. "In addition, ZymoGenetics brings proven capabilities with therapeutic proteins and revenue from a marketed specialty surgical biologic. This acquisition is another example of our strategic, targeted approach to business development."

"By joining forces with Bristol-Myers Squibb, we believe we will enhance the long-term potential of ZymoGenetics' portfolio of assets, while providing a compelling valuation for our shareholders," said Douglas E. Williams, Ph.D., chief executive officer of ZymoGenetics. "Our collaboration with Bristol-Myers Squibb in the development of PEG-Interferon lambda has been extremely positive and it has given us an opportunity to fully appreciate their capabilities. We believe that this transaction will maximize the potential for our products and product candidates to make a meaningful difference for patients in need."

Bristol-Myers Squibb gains the following as a result of the acquisition:

-- Full ownership of pegylated-interferon lambda, a novel interferon in Phase IIb development for the treatment of Hepatitis C infection, which, if approved, could be an important contributor to Bristol-Myers Squibb's future growth. The companies have collaborated on the development of pegylated-interferon lambda since January 2009. Four-week and 12-week results from a Phase IIa study will be presented at the American Association for the Study of Liver Diseases meeting later this year.

-- RECOTHROM(R), a recombinant thrombin approved by the U.S. Food and Drug Administration for use as a topical hemostat to control non-arterial bleeding during surgical procedures.

-- IL-21 protein, a cytokine currently being tested in an open-label, Phase II clinical study as a potential immunotherapy treatment for metastatic melanoma.

-- An earlier-stage pipeline of six biologic drug candidates, including an anti-IL-31 antibody, currently in pre-clinical development for atopic dermatitis.

-- Potential milestone and royalty payments from six partnered programs in various stages of clinical development by EMD Serono, Inc., an affiliate of Merck KGaA, and Novo Nordisk.

"ZymoGenetics is a leader in advancing novel biologics, particularly genomics-based therapies," said Elliott Sigal, M.D., Ph.D., executive vice president and chief scientific officer, Bristol-Myers Squibb. "We expect ZymoGenetics' pipeline and biologics capabilities to complement and enhance our existing efforts in Hepatitis C, oncology and immunoscience."

Initially, the transaction is expected to be modestly dilutive to earnings per share (EPS) for Bristol-Myers Squibb. In 2010, the transaction is expected to be dilutive to EPS by approximately $0.03. In 2011, the transaction is expected to be dilutive to EPS by approximately $0.07.

Under the terms of the definitive agreement, Bristol-Myers Squibb will commence a cash tender offer on or about September 9, 2010 to purchase all of the outstanding shares of ZymoGenetics' common stock for $9.75 per share. The closing of the tender offer is subject to customary terms and conditions, including the tender of a number of shares which is equal to or greater than 48,282,192 shares (which represents approximately 56% of the outstanding shares as of August 31, 2010, which represent a majority of the shares on a fully-diluted basis, excluding certain shares underlying derivative securities that are significantly out-of-the-money), and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The agreement also provides for the parties to effect, subject to customary conditions, a merger to be completed following the completion of the tender offer which would result in all shares not tendered in the tender offer being converted into the right to receive $9.75 per share in cash. The merger agreement contains a provision under which ZymoGenetics has agreed not to solicit any competing offers for the company. Bristol-Myers Squibb will finance the acquisition from its existing cash resources. The companies expect the tender offer to close approximately thirty days after commencement of the tender offer.

Morgan Stanley & Co. Incorporated is serving as financial advisor to Bristol-Myers Squibb in connection with the acquisition, and Bristol-Myers Squibb is represented by Kirkland & Ellis LLP. Goldman, Sachs & Co. is serving as financial advisor to ZymoGenetics in connection with the acquisition, and ZymoGenetics is represented by Latham & Watkins LLP and Fenwick & West LLP.

Zymogenetics Q2 Edited

Doug Williams

RECOTHROM. Net sales of RECOTHROM were up substantially compared to Q1 of 2010, and were nearly double the net sales in the same quarter last year. Hospital demand for RECOTHROM is continuing to increase steadily, as is our market share. Consistent with our business plan, we're now successfully converting large hospital groups over to RECOTHROM and in parallel have put in place programs to accelerate the actual conversion process inside an institution once this decision has been made. We began to see the positive impact of these programs in June.

Jim Johnson

Net sales of RECOTHROM were $11.9 million for the quarter, nearly doubling from $6 million in the second quarter of 2009. And compared to the first quarter of this year, net sales were up by 32%. The increase was driven by positive trends in hospital demand and market share, plus two other important factors. One was wholesaler inventory patterns. There was no significant change in wholesale or inventory levels in the second quarter, but there was a decrease in the first quarter that reduced our reported net sales and contributed to a higher percentage increase in Q2.

The other important factor was a temporary program designed to accelerate customer conversion, instituted in June, which added approximately $700,000 to our second quarter net sales.

ZymoGenetics Webcast

SEATTLE, May 05, 2010 (BUSINESS WIRE) -- ZymoGenetics, Inc. announced today that Douglas E. Williams, Ph.D., Chief Executive Officer of ZymoGenetics, will present at the Bank of America Merrill Lynch Health Care Conference in New York City on Wednesday, May 12, 2010 at 10:40 a.m. Eastern Time.

A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.

Zymogenetics Q1 2010 - "Soft" Hemostat Market in January

On the RECOTHROM front net sales for the quarter was $9 million. This is doubling of Q1 sales for 2009. January in particular was a very weak month across the hemostat segment and RECOTHROM was no exception. That said, for the quarter actual hospital demand that it's units moving from the wholesaler inventory to hospital end user increased by 14% compared to the fourth quarter of 2009.

RECOTHROM market share in dollars continued to increase in Q1 to approximately 19% versus 17% in the prior quarter. Jim will discuss the factors that influence our reported net sales for the March 31st quarter, but demand in market share continued to grow and based on momentum we see in the market place, we are comfortable with our full year guidance of $48 million to $54 million of net sales............

Net sales of RECOTHROM were $9 million for the quarter, doubling from $4.5 million a year ago. Net sales were approximately the same as the fourth quarter of 2009 even though we had positive trends in units sold to hospitals and market share as Doug described earlier.

There are two primary reasons for this, both of which were related to differences between the timing of hospital purchases and when we record revenue based on sales to wholesalers. First, decreases in wholesaler inventory levels had a significant impact. We estimated there were about 2.4 weeks of sales in the channel at March 31st, compared to about 3.2 weeks at the beginning of the quarter.

Second, the way that the weeks fell in the calendar had a significant impact, in that there was about one week fewer sales included in the three months ended March 31st compared to the three months ended December 31st. Together these two factors caused our reported net sales to be lower than one would expect based on underlying hospital sales trends.............

Brian Abrahams - Oppenheimer and Company

Great. Can you remind us how was [RECOTHROM] reimbursed and what impact the healthcare reforms would you expect?

Stephen Zaruby

Well, as three reimbursement was captured in the cost of any surgery we don’t see there will be any impact on the reform side at all in terms of our pricing and how we capture. So my guess, we are fortunate in that one of the few maybe who are not affected by that..........

David Miller - Biotech Stock Research

Now switching to RECOTHROM for a moment, can we expect the kind of continued slow grind we have seen for RECOTHROM sales on a quarter-over-quarter basis? Going forward, is there some kind of invents that we can look forward to that might provide an inflection or you would be replacing more of the JMI sales out there?

Stephen Zaruby

This is Stephen Zaruby. I think as Doug said we are encouraged by the momentum that we have seen, but moving forward obviously we are very active in the marketplace at all kinds and different touch points and levels be it through our sales force or national accounts people dealing with GPOs and so on and so forth and as Doug said we remain confident in our annual guidance and so it depends how you might forecast or sort of allocate our sales quarter-by-quarter, but we expect to see continued growth and the growth certainly comes largely or entirely at the expense of Thrombin-JMI........

Paul Latta - McAdams Wright Ragen

One another question on the RECOTHROM, you mentioned that the hemostat market was a little soft in January, any thought as to why?

Doug Williams

It's hard to say. I think it was sort of an observation we made looking at the totality of the markets. If you recall Paul we saw similar situation with our fourth quarter to first quarter situation last year, but I don’t know how much of it is sort of seasonally related, but I think beyond the metrics that Jim sketched out in terms of one less week and drawing down the wholesaler inventory levels. Those are really the sort of firm facts we can throw out and beyond that I think we just beat speculation as to what was happening in the market there, but quite clearly January for everyone in the hemostat area was a soft month.

Paul Latta - McAdams Wright Ragen

Is their [year-end] budget plus possibility too?

Doug Williams

Again it's hard to say. I think you could relate it to everything from bad weather on the East Coast to general economic conditions, but I think fundamentally we don't really have a clear-cut answer for you as to why January was soft.

Source: Seekingalpha

ZymoGenetics, Inc. Q4 2009

On the RECOTHROM front, we continue to gain market share and in January we published pooled safety and immunogenicity data across 8 different clinical studies in the Journal of the American College of Surgeons. This data further supports the safety and differentiation of RECOTHROM as a topical hemostat; we have recently been notified by FDA that they will require more time to analyze the mix of the citizen petition we filed in August which was inline with our expectations for their actions. Less visible but no less important will be the GMP manufacturing of the IL-31 monoclonal antibody and the initiation of IND enabling toxicology studies to support a first half 2011 IND Filing.

The company proceed of $13.6 million profits for the quarter which resulted from a one set of recognition at differed revenue related to restructuring of the their agreement. It was the positive quarter financially was increased RECOTHROM sale further reductions in ongoing operating expenses. A $94 million of cash inflow is from milestone payments.

All of our financial goals for the year ending with the strong cash position strengthen further by the additional $91 million rate of last month. Net sales of RECOTHROM increased $10.6 million for the quarter including 1.4 million (inaudible) to try the clinic launch in Canada. For the year sales of (inaudible) firm within our range of guidance further in asset sales to be included. At the hospital level we continue to see increasing demand in Q4, we estimated the growth that approximately 18% compared to the third quarter. Cognition and license revenue for the quarter were $51.2 million and the largest component of this total was the acceleration of $34 million related to their agreement.

ZymoGenetics Closes $90M Deal

ZymoGenetics, the Seattle-based biotech company, said today its underwriters have exercised their options to buy all the shares they were granted, bringing its net proceeds from the latest offering to $90.9 million. Investors and underwriters bought a total of 16.1 million shares at $6 apiece, ZymoGenetics said. The money will be used to support R&D, and to help market the company's lone approved drug, recombinant thrombin (Recothrom).

ZymoGenetics to sell 12 million shares

Jan 6 (Reuters) - Biotechnology firm ZymoGenetics Inc (ZGEN.O) said it will sell 12 million common shares in a public offering. Shares of the company fell 11 percent to $6.00 in trading after the bell. The proposed offering amounts to about 17 percent of the company's total outstanding shares of about 69.3 million as of Oct. 30, 2009. The company plans to grant underwriters an over-allotment option to purchase up to an additional 1.8 million shares. A portion of the net proceeds from the offering will be used to support the commercialization of its synthetic blood-clotting enzyme Recothrom, the company said in a statement.

ZymoGenetics shares fall on regulatory delay

Shares of ZymoGenetics Inc. dipped Tuesday after the company said additional studies are likely needed to gain European regulatory approval of its only marketed product, Recothrom.
Sales of the drug, which is used to control bleeding during surgical procedures, climbed to $8.5 million from $1.8 million during the third quarter. While approved in the U.S., it is not yet approved in Europe. Seattle-based ZymoGenetics licensed all rights outside of the U.S. to Germany-based Bayer in 2007.
In a Securities and Exchange Commission filing Monday, ZymoGenetics said Bayer pulled its application with European regulators as a response to indications that the drug candidate would take an additional study to gain approval.
The Committee for Medicinal Products for Human Use said Bayer's submission did not meet the necessary standards.
The stock fell 13 cents, or just under 2 percent, to $6.61 in afternoon trading. ZymoGenetics shares have traded between $2.55 and $7.31 over the last 52 weeks.

Zymogenetics cuts back staff to focus on Recothrom

ZymoGenetics is cutting all of its immunology work along with 15 percent of its jobs, or 52 positions. That's in addition to the 161 jobs the developer cut in April when it decided to bow out of the cancer research business. All ongoing immunology discovery research programs will be discontinued; however, the company will keep the research capabilities necessary to support the ongoing development programs for current product candidates.
According to the regulatory filing, cutting new immunology research will allow the developer to focus on its sole marketed product, Recothrom Thrombin, a treatment for surgical bleeding. It will also give ZymoGenetics more resources for developing and commercializing its pipeline of clinical and preclinical product candidates. In a statement emailed to Xconomy, a spokesperson said that the company has abandoned the strategy of discovering and licensing out many early-stage candidates. Now it will focus on fewer programs that it will advance to later stages. The spokesperson added that the company is focusing on drug candidates that have the most potential over the next three to four years.
ZymoGenetics's reductions will result in an annual expense savings of $8 million to $10 million, in addition to the estimated $30 million in savings generated by the April restructuring. This round of layoffs leaves the developer with about 300 employees, according to Xconomy.

Sometimes only the Lawyers win.......ZymoGenetics says restraining orders lifted

ZymoGenetics Inc. said Friday that a federal judge in Tennessee has removed three temporary restraining orders imposed on the company over marketing and promotion of its lead drug, Recothrom.
The Seattle biotechnology company (NASDAQ: ZGEN) on Wednesday disclosed that it had been slapped with the restraining orders as part of a lawsuit filed by four companies, including rival King Pharmaceuticals Inc. The lawsuit accuses ZymoGenetics of unfair competition, false advertising, trademark infringement and related claims, ZymoGenetics said.
In a filing Friday with the Securities and Exchange Commission, ZymoGenetics said the judge in Tennessee had vacated the restraining orders, which "have no further force or effect." The company did not elaborate, but said it disputes the lawsuit's allegations and intends to "vigorously defend" itself at a hearing in the case scheduled for Nov. 16.
ZymoGenetics on Thursday said third-quarter revenue increased 131 percent, to $8.5 million, from the same quarter a year ago, due to sales of Recothrom, a bleeding-control drug. The company narrowed its Q3 loss to $11.4 million, or 17 cents a share, from a loss of $28.8 million, or 42 cents a share, in the year-ago quarter.

King Pharmaceuticals Inc has sued ZymoGenetics Inc

Nov 4 (Reuters) - King Pharmaceuticals Inc has sued ZymoGenetics Inc seeking damages and injunctive relief, alleging trademark infringement among other things, and a U.S. court has temporarily restrained Zymogenetics from marketing a product, according to a regulatory filing.
ZymoGenetics said in the filing that the three temporary restraining orders (TROs), passed on Nov. 3 without hearing its side, were prohibiting it from engaging in certain marketing or promotional conducts related to Recothrom, its hemostasis aid.
ZymoGenetics said King, in the suit filed in a federal court in Tennessee, alleged Zymogenetics of engaging in unfair competition, false advertising, trademark infringement and other related claims.
"We are seeking immediate relief from the court to vacate the TROs, and we will seek an immediate hearing on this motion," ZymoGenetics said in the filing.
A hearing on King's motions for preliminary injunctive relief is scheduled for Nov. 16, and ZymoGenetics will oppose King's request for preliminary injunctive relief, it said.
"We currently believe that this litigation will not have a material adverse effect on our financial condition, our results of operation, or our cash flows," ZymoGenetics added.

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