ZymoGenetics pushes to increase lackluster sales of only drug

ZymoGenetics said Tuesday that quarterly sales for its only commercial product increased by 27 percent but still fell short of expectations, spurring a new strategy to ramp up sales.
"Sales are still low, and our focus is and must be to grow sales as quickly as possible," said Chief Executive Bruce Carter in a conference call to discuss its quarterly financial results.
The product, Recothrom, is a genetically engineered form of thrombin, a blood factor used to control surgical bleeding. Net sales of the product amounted to $1.8 million in the third quarter, versus $1.4 million in the preceding quarter.
The Seattle company reduced prices at the beginning of October and is undertaking a more aggressive campaign highlighting the risks of Recothrom's competitor, a similar product derived from bovine blood. Sales are being held down by hospital concerns about prices and limited awareness among doctors about the compound.
ZymoGenetics posted a third quarter net loss of $28.8 million, or 42 cents per share, down from $39 million, or 57 cents per share, in the same period last year.
ZymoGenetics launched Recothrom in January amid great expectations, but the market has been skeptical about the company's ability to achieve higher sales. Its stock price has suffered accordingly.
Last year ZymoGenetics was the region's largest independent biotech by market capitalization, and its share price peaked at $15. On Tuesday, shares traded at $3.85, up 3 percent; the company's market cap now ranks third among local biotechs.
In May, McAdams Wright Ragen analyst Paul Latta cut his 2008 sales outlook to $18 million from $30 million; other analysts more recently reduced that estimate to about $12 million.
On Tuesday, ZymoGenetics issued its first official guidance for Recothrom, predicting 2008 sales of $7 million. In the long term the company expects to lead the market for thrombin, said spokeswoman Susan Specht.
Some analysts have estimated that eventually Recothrom sales could reach $300 million to $400 million.

The Clotting Cascade and Blood

Highlights Cryolife Q3

BioGlue revenues were a record $36.5 million for the first nine months of 2008, compared to $32.4 million in the first nine months of 2007, an increase of 13%. This increase was primarily due to the aggregate impact of a favorable product mix, and a 4% increase in the number of BioGlue milliliters shipped, which increased revenues by 10%, and an increase in average selling prices, which increased revenues by 3%..........

Other medical device revenues in the third quarter and nine months of 2008 included $549,000 and $726,000 in sales of Hemostase MPH, which we began distributing in May of this year.........

During the quarter we were awarded another grant of $848,000, of which $212,000 has been received from the Department of Defense for our continued development of our BioFoam surgical matrix product. Our CE mark application for BioFoam is targeted to be submitted to our European notified body in December. We would expect that we would receive approval for the BioFoam CE mark in April of ’09.
Our plans are to launch this product throughout Europe beginning in the second quarter of 2009. After CE approval, we plan to conduct several post-approval studies to evaluate BioFoam in liver resections. These will be conducted at three European clinics, with approximately 15 patients per clinic.
For approval in the United States, we will need to submit an IDE application and conduct a clinical trial. We are currently targeting a December submission for the BioFoam IDE. The U.S. human study indication will be as an adjunct to control bleeding following liver resection surgery. We will initially be requesting a pilot clinical study at one or two centers, in 10 to 20 patients. We would expect our follow on pivotal U.S. study to include up to 200 patients. We estimate that it will take about two years to complete the pilot and pivotal studies in the United States.........

Other medical device revenues, which consist primarily of sales of Hemostase MPH, are expected to be between $4.5 and $5.5 million in 2009. Product and tissue processing revenues could be affected by several factors, including but not limited to, the general economic environment, and its effect on demand for the company’s products and processed tissues, and changes in foreign currency exchange rates, and their effects on revenues generated in international markets. Again, this guidance assumes foreign currency exchange rates stay near current levels...............

And from the Q & A.

Greg Brash - Sidoti & Company
Okay, and is the -- just one last question, is the Hemostase MPH, is that tracking your expectations? Are you pleased with how the product is selling and the physician feedback?
Ashley Lee
Yes, we are, we’re getting a lot of attraction with that product, and we think it’s also very complimentary to BioGlue, and we think that it’s had some impact on the BioGlue sales increases.
Greg Brash - Sidoti & Company
Okay, I mean do you think doctors are pretty brand-loyal on this market? Obviously, you’re doing pretty well, and you’re still initial launch year, but are they pretty open to trying the product?
Ashley Lee
They are open to trying the product. When you see it work, it’s a very impressive visual reaction, because it works instantaneously so I think from that stand and it’s effective, so I think that it will continue to grow.
Greg Brash - Sidoti & Company
Okay, thanks guys.

Source: seekingalpha

CPC Appoints Medical Product Service GmbH as Authorized European Representative for MedClose

SARASOTA, Fla., Oct. 29 /PRNewswire-FirstCall/ -- CPC of America, Inc.(OTC Bulletin Board: CPCF), a company focused on the development of therapeutic devices for use in endovascular procedures, today announced that it is implementing a European strategy for the development and distribution of its MedClose(TM) investigational-stage medical device. In the roll out of its strategy, CPC announced an agreement with Medical Product Service GmbH (MPS) of Germany to act as authorized European representative for the Company in seeking European regulatory approval for MedClose(TM) Vascular Closure Device(VCD). MedClose(TM) is an extravascular puncture-closure device intended to be used with a biological sealant for diagnostic and interventional cardiovascular procedures. According to published third party research, European VCD market sales for2008 are projected to total approximately $160 million. Industry experts forecast that in Europe, the penetration of VCDs into minimally invasive cardiovascular procedures will experience a 9% compound annual growth rate and drive VCD sales and revenues."The European Union offers significant opportunities to broaden theMedClose(TM) market potential," said Rod Shipman, chairman and chief executive officer of CPC of America. "By aligning ourselves with MPS, we are setting a critical path to market in Europe. Our team will work closely with MPS inbuilding key partnerships and navigating the European regulatory regime and clinical trials. We recognize the need for a safe, reliable closure system that reduces time to hemostasis and allows for faster patient ambulation and,when necessary, wound re-access. With MedClose(TM), we aim to fill that need in the U.S. and Europe."As CPC's authorized representative in Europe, MPS will provide service under the respective CE marking requirements that apply in the European Union.MPS's role will include vigilance reporting, communicating with competent authorities in individual member states, assisting in securing international product registrations, and preparing and completing dossiers for clinical trials and CE markings."MPS knows that physicians operating in catheter laboratories across theEU demand precise instruments that help improve patient safety and outcomes,"said Gehard Fromel, Principal Regulatory Consultant of MPS. "We are eager to collaborate with CPC to bring to market a product that may help the European medical community and their patients."
About Medclose
The MedClose™ VCS is a medical device that is designed to seal femoral arterial puncture sites in patients who have undergone diagnostic or interventional catheterization procedures. It utilizes a proprietary catheter delivery vascular closure system that is designed to enhance manual compression by delivering a biologic sealant which creates an elastic coagulum that is fully resorbed within 10 to 14 days.

Falling apart over Omrix

When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment. It now turns out that while Omrix may not be of the all or nothing genre, it is a real madhouse for investors like me, who were looking for an oasis of tranquility in the biotechnology sector, a sector that has traditionally been fraught with risk.
Since the beginning of the year, Omrix has managed to issue a severe warning (in March) for the fourth quarter of 2007, plunge heavily, and replace its CFO a second time. At the beginning of this month, on the eve of Yom Kippur of all times, it issued an announcement in which it reported positive interim results in the important trial of its advanced surgical sealant, following which the share rose strongly, just as the collapse on the markets was moving into high gear. The news made the fast a bit easier to handle, but the joy was short-lived.
By the next day, Yom Kippur itself, Omrix had already updated investors with the announcement that it was halting the trial due to the occurrence of a critical fault, just a day after declaring it a success. Investors like me switched on their computers after Yom Kippur ended, only to find that the share had plummeted for the second time in six months. Later on in the month, Omrix tried to put the fiasco of the failed trial behind it with a reassuring announcement to investors about a strong third quarter. But Omrix's weary investors found little cause for cheer, and the share barely moved at all.
The denouement came last Friday when Omrix joyfully announced the resumption of the trial, as if nothing had happened at all. "We got it wrong, there was no fault," was what the announcement amounted to, and the company's share regained just a small part of the ground it lost on Yom Kippur. One can imagine how investors, who abandoned the stock on Yom Kippur after it crashed 40% following the announcement of the fault, felt last Friday when Omrix revealed it never actually happened.
The analysts covering Omrix are also finding that their patience is wearing thin. In its latest review, Citigroup describes the company's astounding u-turn as "one step forward, three steps back, one step forward." It assumes that the fault occurred for one of two reasons - either a technical failure due to human error, or bleeding in another place not treated by the sealant. Until such time as they receive further clarification, which will most likely be forthcoming on November 6, when Omrix unveils its results, Citigroup's analysts are retaining the lukewarm "Hold" recommendation they issued following the company's stiff warning in March, with a target price of just $15.
On top of all this, the Omrix roller coaster has been dogged by sporadic rumors that it could be sold for around $25 a share. The identity of the possible buyers regularly changes. Among those rumored to be in the frame are Ofer Group, Johnson & Johnson Inc. (NYSE: JNJ), Omrix's partner in the marketing and development of the aforementioned sealant and, according to "Globes", also European pharmaceutical giant Bayer AG (LSE: BYR; XETRA: BAY).

Source: Globes

Omrix Biopharmaceuticals Announces Patient Enrollment Will Resume In Fibrin Pad U.S. Phase II Clinical Trial In Mild to Moderate Bleeding

Omrix Biopharmaceuticals, Inc. ("Omrix”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that the Fibrin Pad U.S. Phase II clinical trial in mild to moderate bleeding will resume patient enrollment and continue with no modifications.
On October 9, 2008, the Company announced that the U.S. Phase II clinical trial had been suspended in order to investigate an incident of post-operative bleeding. This event met the stopping rules, as outlined in the clinical trial protocol.
Per the clinical trial protocol, upon the suspension of the study, a Data Safety Monitoring Board, or DSMB, reviewed the data related to the event. The DSMB has concluded their investigation and authorized the trial to recommence.
About the Fibrin Pad
The Fibrin Pad builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.

Excerpt Vascular Solutions Inc. Q3 2008

.........Our highest sales product category in the third quarter was our hemostat products, with $5.8 million in net revenue in the third quarter, a decrease of 4% from the third quarter of 2007. The three causes for the decline were the continued reduction in sales of our Duett sealing device, which is our legacy product that we have chosen to not actively promote, the as-planned conversion from hospital pricing to distributor pricing in Germany as a result of the switch to a distributor sales model, and the decline in sales to King Pharmaceuticals.
In the third quarter of 2008, King purchased $90,000 of Thrombi-Gel and Thrombi-Pad, with an additional order planned but delayed by us until the fourth quarter due to our recently completed facility expansion. We recently -- we expect King purchases to continue at the current level until we receive FDA approval for the surgical indication for the Thrombi-Gel product, which we currently target for the end of 2009.
D-Stat Dry sales were essentially constant on a sequential quarter basis, as we have maintained our leading market share in the face of intense price competition from the non-thrombin patches.

Omrix Q3 revenue beats Wall Street view

Oct 20 (Reuters) - Biopharmaceutical company Omrix Biopharmaceuticals Inc reported a 35 percent rise in its third-quarter revenue, beating analysts' average estimate, and raised its full-year product sales outlook.
The company reported preliminary quarterly revenue of $21.3 million, compared with $15.8 million a year earlier. Analysts on average expect the company to post a revenue of $19.1 million, according to Reuters Estimates.
Omrix sees 2008 product sales of $70 million to $72 million, up from its prior forecast of $68 million to $71 million.
The company reaffirmed that it expects its biosurgery product sales in 2008 to increase about 75 percent from a year ago.
The company said its product sales guidance is partly based on the current biosurgery sales outlook provided by Ethicon Inc, a unit of Johnson & Johnson.
Ethicon has exclusive sales and marketing rights to Omrix's biosurgical products in the United States and the European Union.
Omrix shares closed at $14.48 on Friday on Nasdaq.

New Cardiology Agreement for Abbott

CHARLOTTE, N.C., Oct 09, 2008 (BUSINESS WIRE) -- Premier Purchasing Partners, LP, today announced new agreements for hemostasis and compression products for use in cardiology with Abbott Laboratories, Inc. of Abbott Park, Ill., and TZ Medical, Inc. of Portland, Ore.
The 36-month agreements, effective November 1, 2008, are available to acute and continuum of care members of the Premier healthcare alliance.
About Premier Inc., 2006 Malcolm Baldrige National Quality Award recipient
Serving more than 2,000 U.S. hospitals and 53,000-plus other healthcare sites, the Premier healthcare alliance and its members are transforming healthcare together. Owned by not-for-profit hospitals, Premier operates one of the leading healthcare purchasing networks and the nation's most comprehensive repository of hospital clinical and financial information. A subsidiary operates one of the nation's largest policy-holder owned, hospital professional liability risk-retention groups. A world leader in helping healthcare providers deliver dramatic improvements in care, Premier is working with the United Kingdom's National Health Service North West and the Centers for Medicare & Medicaid Services to improve hospital performance. Headquartered in San Diego, Premier has offices in Charlotte, N.C., Philadelphia and Washington. For more information, visit www.premierinc.com.

Cohera Medical Wins Pittsburgh Technology Council's 2008 Tech 50 Rising Star Award

PITTSBURGH, Oct. 20 /PRNewswire/ -- Cohera Medical Inc. today announced that it has received the Pittsburgh Technology Council's 2008 Tech 50 Rising Star Award. The Tech 50 Awards recognize accomplished technology-oriented companies in southwestern Pennsylvania. The Rising Star award is given to a young (less than three years old) entrepreneurial company that offers the most unique products or services among the contending companies and shows promise of becoming a significant economic force in the area. "We are extremely pleased that Cohera Medical's tissue adhesive technology has been recognized for its innovation and economic potential,"said Patrick Daly, chief executive officer of Cohera Medical. "TissuGlu(R),our lead product candidate for use in securing planes of tissue in plastic surgery procedures, is a truly novel product candidate that shows significant potential for improving clinical outcomes and patient care. We also look forward to developing our surgical adhesive technology for otherproducts as well."

About Cohera Medical Cohera Medical Inc. is a Pittsburgh-based company that is developing are volutionary line of wound management products and surgical adhesives.Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is a sprayable bonding agent for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation and small bone fixation, which will fill similar market needs in both orthopedics and general surgery. For more information, visit http://www.coheramed.com. TissuGlu and the other Cohera products have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or by any other country's regulatory authority.