Saturday, April 5, 2014

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."

Sunday, March 23, 2014

Drug companies developing longer-acting clotting agents for hemophiliacs

Several drug companies, such as Biogen Idec and Novo Nordisk, are developing new, longer-acting versions of the blood clotting factors used by people with hemophilia. Patients with severe forms of the disease need regular infusions, lasting 30 minutes or more, of relatively short acting and very expensive clotting factors.

The new longer-lasting hemophilia B products can be given every 10 days or two weeks, offering significant advantages for patients, especially young children, who now need infusions every two or three days.

Hemophilia is hereditary, passed from parent to child through genes. People with hemophilia have little or no clotting factor. Hemophilia A and Hemophilia B have different clotting factors that are low or missing, but both can experience spontaneous bleeding, as well as severe bleeding following injuries or surgery.

Worldwide, about one in 5,000 men is born with hemophilia A and one in 25,000 men is born with hemophilia B each year. Since the gene is carried on the X chromosome, hemophilia is almost entirely a disease of men. Women can pass the gene to their offspring. Hemophilia has often been called the “Royal Disease” since it was carried by Britain’s Queen Victoria and affected many of the ruling families of Europe. Blood factor concentrates were not developed until the mid-20th century, and up until that time people with hemophilia had a life expectancy of less than 30 years.

The U.S. Food and Drug Administration is due to decide by mid-year whether to approve a new long-lasting hemophilia B clotting factor from Biogen Idec. Novo Nordisk expects to file next year for regulatory approval of its long-acting hemophilia B drug.

Some industry experts say these and other new treatments could help drive down the price of existing hemophilia products, which can total $300,000 or more a year for a single patient.

Saturday, March 22, 2014

Mercy adopts new blood cell transfusion guidelines

SIOUX CITY | Mercy Medical Center -- Sioux City has stepped up efforts to conserve red blood cells.
All hospitals in the Trinity Health network have applied the new national recommendations developed by The Joint Commission and the American Medical Association -- convened Physician Consortium of Performance Improvement that advise adopting a "more restrictive" practice of red blood cell transfusion to produce better patient outcomes.
"We want to give just what is necessary, one unit at a time," said Dr. Gregg Galloway, a pathologist and vice chair of the Infectious Disease Committee at Mercy. "Give him a unit of blood. It will make him feel better -- that's the old paradigm. We don't believe it anymore."
Mercy has always had guidelines in place instructing staff when to give red blood cell transfusions, but Galloway said those rules have significantly changed and are "more restrictive" than they used to be.
"We're doing it because we do believe it is better quality patient care at all health care institutions and because of the cost of the resources," he said.
The new guidelines were released following a September 2012 national summit that convened representatives from 112 professional organizations and associations in effort to curb overuse of five medical treatments. Transfusion of red blood cells in hospitals was one of them.
A decade of studies, according to Galloway, found that when "more restrictive" red blood cell transfusion practices were used, hospitalized patients had lower mortality rates, fewer complications from infectious diseases, less breathing problems and cardiac events, as well as a reduced chance of developing acute respiratory distress syndrome -- a life-threatening lung condition that prevents enough oxygen from getting to the lungs and into the blood.
Galloway said hospital staff give patients red blood cell transfusions based on their hemoglobin (a protein in red blood cells that carries oxygen) and hermatocrit values (percentage of red blood cells found in whole blood). When their hemoglobin value dropped below 10 grams per deciliter (G/dL), the patients received a transfusion. The "more restrictive" guidelines, he said, don't recommend transfusion until hemoglobin values fall between 7 and 8 G/dL.
"Big difference. You're going to use less red cell and units in the hospital," he said. "We predict that overall we'll have a 15 to 20 percent drop over the next year and a half to two years in our red cells that we'll use in our hospital setting."
Once blood is collected at a donation center, it's processed, placed in a refrigerator and stored. Chemical changes, he said, occur in the hemoglobin, and red blood cells lose their malleability.
"Those red blood cells start to change," he said. "They are no longer like the normal red blood cells you and I have floating around in our body. Banked blood is a tissue transplant. Those are somebody else's red cells."
In addition to the new guidelines, Galloway said, improvements in surgical techniques that reduce the need for red blood cell transfusions in the operating room are also contributing to the downward trend.
Surgeons are encouraged to salvage patients' blood in the operating room, a practice that was once reserved for open heart surgery. Now it's being used in trauma, abdominal aneurism and orthopedic surgeries.
"We're trying to save the patient's own blood. We re-process it in the OR and we give it back to them," Galloway said. "We also have new hemostatic medications that we can give patients that keep them from bleeding as much in OR."
Large hospitals, he said, now have blood management programs that staff nurses who review a patient's clinical situation alongside the guidelines. Some patients seeking elective surgery, he said, may have to wait longer to get into the operating room if they lack enough healthy red blood cells.

Adhesion Incidence and Severity Vary by Surgical Procedure

Experts estimate approximately 93% of patients who have undergone laparoscopic surgery develop abnormal fibroid bands that bind organ surfaces to the abdominal wall after a second surgery. Many adhesions are asymptomatic, but in some patients, they can cause pain, small bowel obstruction and other postoperative issues, as well as increase cost and complicate surgical suite workload. As surgeons underestimate the rate of adhesion development given that up to 93% of consent forms don’t address them, the March 2014 issue of Surgery Today contained a systematic review estimating the formation rate, distribution, and severity of postoperative adhesions in abdominal surgery patients.
After reviewing 25 studies published between January 1990 and July 2011, the authors determined the weighted mean formation rate of adhesions after abdominal surgery was 54%. However, different types of surgeries and procedures had different adhesion statistics. Among patients who had gastrointestinal (GI) surgery, 66% developed adhesions. In patients who had gynecologic and urologic surgeries, the rates were 51% and 22%, respectively.
Since those rates were lower than the numbers reported a few decades ago, the authors suggested current practices such as minimizing peritoneal foreign body exposure, careful tissue handling, meticulous hemostasis, specific closure of the peritoneum in caesarean sections, and modern surgical techniques have helped reduce the rate of adhesion.
The authors reported laparoscopic surgery reduced the adhesion formation rate by 25% and also decreased the adhesion severity score for Gl surgery.  They concluded heightening awareness of adhesions is needed to shed light on the complication’s etiology. With better understanding of how and why adhesions form, researchers will be able to develop novel therapeutic approaches, the authors said. They also suggested the potential for adhesions should be addressed clearly in consent forms.

Friday, February 7, 2014

Popular Blood-thinner Manufacturer Didn’t Want Internal Research Made Public

Boehringer Ingelheim, the manufacturer of the blood-thinning drug Pradaxa, was concerned that releasing the results of an internal research paper on the drug would damage drug sales, records recently made public show. The company was so worried about the results of the study that some employees pressured the author to revise it, and the company recommended it be thrown out, according to a recent report by the New York Times.

Records recently made public by a federal judge in Illinois presiding over thousands of lawsuits against the maker of Pradaxa, including emails, internal memos, and presentations, centered on the research project and whether it would be damaging to Pradaxa’s main selling point: that users of the drug aren’t required to undergo regular blood work while taking Pradaxa.

Pradaxa (dabigatran) was approved in 2010 as an alternative to an existing anti-clotting drug, warfarin. Both are anticoagulants used to prevent and treat blood clots and reduce the risk of stroke, but Boehringer Ingelheim marketed its drug as less of a nuisance than warfarin, which requires frequent blood tests and careful monitoring.

Unfortunately, Pradaxa has been linked to more than 1,000 deaths in the United States. Since 2010, an unprecedented number of adverse events related to the drug have been reported to the FDA. Experts have also questioned the reliability of an FDA study affirming the safety of Pradaxa.

Pradaxa has claimed superiority to warfarin. However, documents prepared by the FDA clearly state that “It is important… not to provide dabigatran with a superiority claim to warfarin, because it would imply that even those well-treated with warfarin should be switched to dabigatran. Clearly, that is not the case.”

Furthermore, a research paper written by Paul. A. Reilly, a clinical program director with Boehringer Ingelheim indicates that patients could benefit from having their blood monitored while taking Pradaxa. Reilly states that some patients absorb too little of the drug, rendering it ineffective, while some absorb so much that their risk for bleeding increases.

According to the New York Times, after Reilly’s paper was circulated within the company, Dr. Jutta Heinrich-Nols, a company supervisor, sent an email stating that she couldn’t believe the company was planning to publish Reilly’s work. She warned that publishing his results could make it “extremely difficult” for the company to maintain its claims that patients taking Pradaxa do not need regular blood tests.

Heinrich-Nols also noted that Reilly’s research could “undermine” the company’s efforts to compete with other new anticoagulants like Xarelto and Eliquis. The marketing of Pradaxa is yet another example of the dangers that consumers face when safety information is regulated by pharmaceutical companies primarily concerned with profit.

Boehringer Ingelheim issued a statement saying that the recently-released documents “represent small fragments of the robust discussion and debate that is a vital component in all scientific inquiry and in the research and development of any important medication such as Pradaxa.”

Unlike warfarin, Pradaxa has no antidote to reverse its blood-thinning effects. Despite issues with the FDA’s approach to approving the drug, as well as numerous patient bleeding deaths and adverse event reports, Pradaxa remains on the market as a safe drug.

Arch Therapeutics offers $2.9M in private stock placement

Massachusetts-based Arch Therapeutics hopes to sell over 11 million shares to raise close to $3 million in support of its medical sealants and hemostasis products.

Arch Therapeutics brings in nearly $3M in private stock placement
Arch Therapeutics launched a private placement fundraising effort, offering 11.4 million shares of common stock in hopes of raising $2.9 million.

Wellesley, Mass.-based Arch Therapeutics develops medical sealants and hemostasis products for use during surgeries. The company's marquee device is the AC5 Surgical Hemostatic for minimally invasive and open surgical procedures.

Arch is offering unnamed "institutional and high net worth" investors 11.4 million shares of common stock at a price of 25¢ per share. Investors will also receive warrants to purchase up to 11.4 million additional shares at an exercise price of either 30¢, 35¢ or 40¢ apiece, depending on whether investors purchase from the Series A, B or C warrants, according to a press release.

Arch Therapeutics completed a share swap and reverse merger, to expand into a life sciences company. Arch reported a $7.3 million financing through a share-swap related to its reverse merger with Arch Biosurgery, which expanded the company's range of products and services.

Tuesday, January 28, 2014

Baxter sues Johnson & Johnson over FloSeal patents

Baxter (NYSE:BAX) accused Johnson & Johnson (NYSE:JNJ) of infringing 6 patents covering its FloSeal line with the Ethicon SurgiFlo line of competing surgical hemostasis products.

In a lawsuit filed last week in the U.S. District Court for Northern Illinois, Baxter said the alleged infringement is willful and asked Judge Sharon Johnson Coleman for triple damages, pre- and post-judgment interest, legal costs and a jury trial.

"Defendants' SurgiFlo products directly compete with Baxter's biosurgery products, including the Floseal family of products, which practice the Patents-in-Suit. On information and belief, defendants are aware of Floseal's established position in the hemostatic products market and carefully track Baxter's marketing and other activities related to the Floseal products in the United States and worldwide. For example, one or more of Defendants have repeatedly communicated with Baxter regarding competitive marketing issues in the United States and abroad pertaining to Floseal and SurgiFlo," Baxter alleged, according to court documents. "Defendants have infringed and will continue to infringe Baxter's intellectual property rights by making, using, selling, offering for sale within the United States and/or importing into the United States delivery products for hemostasis such as the SurgiFlo family of products."

Thursday, January 9, 2014

Sealant Inspired By Beach Worm Could Become Surgical Superglue

Remember that wacky glue commercial from the 1980s? "Krazy Glue, you crazy rat," the narrator says. "Strong enough to hold this man suspended in mid-air." He promises the stuff can bond almost anything: a plastic knob, a plastic plug, a rubber boot, a door knob, and even a flashlight case.

Heck, a version of the everlasting adhesive is even approved by the Food and Drug Administration to seal skin wounds.
But superglue can't fix a broken heart — or even a torn artery. Yet.
Now a team of doctors and engineers at Brigham and Women's Hospital in Boston are getting close to changing that. Their unlikely inspiration is a 3-inch worm that lives off the coast of California.
Cardiac surgeon Pedro del Nido and his colleagues have developed a biodegradable adhesive that can patch a hole in a pig's heart or artery. The experimental glue is nontoxic and is strong enough to hold up under the high pressures in the human heart, the team report Wednesday in the journal Science Translational Medicine.
So far, they've tested the glue only in animals. So the sealant is far from reaching the operating room or battlefield. But del Nido hopes the adhesive will eventually replace traditional sutures and staples for some operations, especially heart surgery.
"A glue is the holy grail for repairing hearts," del Nido tells Shots. "Right now we use sutures. Every time the needle and thread enter normal tissue, they do a little bit of damage. Usually it doesn't matter. But I repair children's hearts. For those, this damage can really be a problem."
Regular superglues don't work well inside the body. "It's a skin glue," del Nido says. "You can't use it internally because it hardens as soon as it comes into contact with water." And the glues are made from a compound called cyanoacrylate, which can be toxic.
To find a safe adhesive that could work on hearts, arteries and other organ surfaces, del Nido teamed up with bioengineer Jeffrey Karp, also at Brigham and Women's Hospital.
"In our lab, we look to nature for inspiration in designing materials," Karp tells Shots. "Solutions are really all around us." Karp's lab has been looking at porcupine quills for insights that could lead to better surgical needles.
The barbs on porcupine quills make it easier from them to penetrate the skin.
For the heart glue, Karp and his team turned their attention to critters that stick to slippery surfaces, such as slugs, spiders and a bristly little worm that glues itself rocks in tidal pools, called thesandcastle worm.
To eat, chitons use their teeth, which look like black bulbs with bluish highlights, to grind up rock.
"We started looking at how creatures, like the sandcastle worm, could attach to wet surfaces," Karp says. After years of experimenting with various chemical cocktails, he and his team finally stumbled upon an adhesive that's biodegradable and nontoxic.
"Cells and tissues can grow over the material and into it," he says. Eventually it just dissolves into the body. And the glue only hardens when UV light shines on it. So a surgeon can put the glue in exactly the right place before it seals up.
Although Karp and del Nido haven't tested the experimental glue on people yet, they've put the adhesive through a whole battery of tests in animals.
"We made a hole in the heart of a living rat and showed that we can seal it up without removing the blood," Karp says. "The animals were fine six months later."
They also patched a pig's heart and carotid artery with the glue. Even after the pig was given a shot of adrenaline and its heart pressure shot through the roof, the patched stayed on the tissue.
Of course, humans are more complicated than pigs and rats. And the glue has to be safe for decades in people, not months.
But Karp is so confident that the adhesive will one day reach surgeon's toolbox that he has procured $11 million to start a company to manufacture and test the glue. "It appears that the glue is safe," he says. "But we do need to do more studies. We'll repeat the animal tests and then move forward in humans."

Arch Therapeutics to Webcast Live From the Biotech Showcase Investor Conference

WELLESLEY, MA--(Marketwired - Jan 8, 2014) - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), a life sciences company and developer of AC5(TM), a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to announce that Terrence W. Norchi, M.D., CEO of Arch Therapeutics will present at The Biotech Showcase(TM) 2014 conference on Monday, January 13th, at 5:00PM PST. Attendees will find the presentation scheduled for "Track C" in the Mission II room at that time. Dr. Norchi's presentation will provide insights into the Company's ongoing activities to commercially develop novel technologies into a suite of new products targeting markets of unmet clinical need.
A live webcast of Dr. Norchi's Biotech Showcase presentation can be accessed at the following URL: http://www.media-server.com/m/p/8hcwd8zu.
The Biotech Showcase(TM) 2014 Conference (www.ebdgroup.com/bts) takes place January 13-15, 2014 at the Parc 55 Wyndham Hotel, located at Union Square, San Francisco, California. The Biotech Showcase(TM) is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies an opportunity to present to, and meet with, investors and pharmaceutical executives during the course of one of the industry's largest annual healthcare investor conferences. Now in its sixth year, Biotech Showcase is expected to attract upwards of 1,500 attendees.
About Arch Therapeutics, Inc. (OTCQB: ARTH)
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate, known as AC5(TM), is being designed to achieve hemostasis in minimally invasive and open surgical procedures. Find out more at www.archtherapeutics.com.

Tuesday, January 7, 2014

Z-Medica Signs HealthTrust Agreement

WALLINGFORD, Conn., Jan. 6, 2014 -- /PRNewswire/ -- Z-Medica, a leading developer and marketer of hemostatic agents, announced it has signed an agreement with HealthTrust, a group purchasing and total cost management solutions company,  to provide its healthcare member facilities access to QuikClot® products under a vascular closure patch category, effective January 1, 2014.

"Controlling bleeding in a hospital setting is essential for minimizing the length of procedures, reducing the risk of complications, reducing the cost to patients and medical facilities and improving overall patient outcomes," said Jack McCarthy, vice president of U.S. healthcare sales at Z-Medica. "We are very pleased to be working with the experienced HealthTrust team in this important effort to bring QuikClot products to more healthcare providers and patients who can benefit from them." 

QuikClot products are impregnated with a mineral called kaolin that has been clinically shown to accelerate the body's natural coagulation cascade, helping healthcare professionals, first responders, law enforcement officers, consumers and adventure and outdoor sports enthusiasts rapidly control bleeding. Kaolin is a naturally-occurring, inorganic mineral that does not contain any botanicals, biological material or shellfish products and does not cause any exothermic reaction or vascular complications. QuikClot products are credited with helping thousands of people survive traumatic blood loss every year.