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FDA approves Actonel with calcium for treatment of postmenopausal osteoporosis

The Food and Drug Administration approved The Alliance for Better Bone Health's Actonel tablets with calcium (risedronate sodium/calcium carbonate) to prevent and treat osteoporosis in postmenopausal women.

The new formulation of Actonel, a bisphosphonate, is the first prescription treatment for osteoporosis to include calcium, according to the Alliance, a collaboration between Procter & Gamble and Aventis Pharmaceuticals Inc.

Actonel with calcium is dosed in four-week regimens. Each week contains seven tablets; one tablet is a weekly dose of Actonel 35 mg, and the other six are 500 mg calcium tablets.

Calcium was added to the treatment regimen "in light of the recent Surgeon General's Report on Bone Health and Osteoporosis, which emphasizes the need for osteoporosis regimens to be simplified and organized," the Alliance noted.

Two surveys conducted on behalf of the Alliance found that many women do not correctly take calcium with their bisphosphonate treatments. In a survey that included 498 households of women who filled a bisphosphonate prescription during a one-year period, Information Resources Inc. found that 73 percent of these women bought less than the equivalent of one calcium tablet per day. A survey by Harris Interactive Inc. that included 372 bisphosphonate users aged 50 years or more found that approximately 26 percent of the respondents took their calcium supplements within 30 minutes of taking a bisphosphonate, thereby decreasing the effectiveness of the bisphosphonate.

"Many women need to understand the importance of how to follow a proper daily calcium regimen to realize the full effectiveness of an osteoporosis regimen that includes a bisphosphonate," said Dr. Steven Goldstein, a professor of obstetrics and gynecology at the New York University School of Medicine. "The Actonel with calcium packaging system offers women a new way to take their Actonel and their calcium correctly and consistently."

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Fortical Nasal Spray approved for treating postmenopausal osteoporosis

The Food and Drug Administration granted approval to Unigene Laboratories Inc.'s Fortical (calcitonin-salmon [rDNA origin]) Nasal Spray, which is indicated to treat osteoporosis in women more than five years postmenopause who have low bone mass relative to healthy, premenopausal women.

Fortical will be manufactured by Unigene; Upsher-Smith Laboratories Inc. will be responsible for packaging, marketing and sales in the United States. Under an exclusive U.S. licensing agreement between the two companies, Unigene will receive a final $4 million milestone payment and future royalties on product sales.

"We are understandably excited to receive FDA approval for our first pharmaceutical product in the United States," said Dr. Warren Levy, chief executive officer of Unigene. "We expect that the revenues generated from sales of Fortical will allow us to strengthen our financial position and expand our activities into new applications of our patented peptide manufacturing and oral delivery technologies."

Mark Evenstad, president of Upsher-Smith, noted that the osteoporosis market grew nearly 18 percent in 2004 to $4 billion.

Unigene filed the New Drug Application for Fortical in March of 2003 and received an approvable letter from the FDA in January of 2004.

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FDA approves use of Merck's Vaqta hepatitis A vaccine in younger children

Merck & Co. Inc.'s Vaqta (hepatitis A vaccine, inactivated) received approval by the Food and Drug Administration for use in children aged 12 months or older.

The injectable vaccine was already approved for use in patients aged 2 years or older.

The newest approval was based on results from an open-label trial that evaluated indicators of immune response to Vaqta after a second dose was administered to 343 children aged 12 to 23 months who had no evidence of hepatitis A infection. Merck said all patients developed protective immune responses. Additionally, the findings indicated that Vaqta can be given along with M-M-R II, Merck's live virus vaccine for measles, mumps and rubella.

"Surveillance data have shown that young children often transmit hepatitis A in the United States, but since they do not typically show symptoms, they unknowingly pass the infection on to older siblings and parents, who can become very ill from hepatitis A," said Dr. Fernando Guerra, director of health at the San Antonio Metropolitan Health District. He said the expanded indication means "we can help protect children against hepatitis A earlier in life."

Merck advises that pediatric patients receive an initial dose of 0.5 mL, followed by a booster dose of 0.5 mL six to 18 months later.

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FDA says Discovery's response to Surfaxin approvable letter incomplete; shares fall

Discovery Laboratories Inc.'s shares fell 9.5 percent on news that the Food and Drug Administration said the company's response to an approvable letter for Surfaxin (lucinactant) is incomplete. Surfaxin is an investigational treatment intended to prevent respiratory distress syndrome in premature infants.

The company expects to receive written communication from the FDA later this week with more details.

Discovery received the approvable letter in February, which mentioned issues pertaining to the product's labeling, chemistry and commercial production; the company submitted its response letter on July 29.

Robert Capetola, Discovery's chief executive officer, said the response was "encyclopedic and comprehensive."

"Based upon the thoroughness of our response letter, we are optimistic that the FDA's issues will center on a few select items that are capable of being addressed in an as timely and efficient manner as possible," he added.

Discovery shares closed at $6.35, down $0.67, in heavy trading on the Nasdaq.

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Cardiome's Oxypurinol Phase II clinical trial fails to meet primary endpoint

Cardiome Pharma Corp. said Oxypurinol, its experimental drug to treat heart disease, failed to show significant benefits compared with placebo in a Phase II clinical trial.

The placebo-controlled OPT-CHF study included 405 patients with congestive heart failure. The trial measured the impact of a daily oral regimen of Oxypurinol 600 mg, taken for 24 weeks, on the clinical outcomes in patients receiving standard CHF therapy.

The results of the study revealed that Oxypurinol did not demonstrate a statistically significant benefit compared with placebo and therefore did not achieve the trial's primary endpoint. The drug also failed to show any benefit compared with placebo on the Minnesota CHF Quality of Life index and time to acute clinical events, the trial's secondary endpoints.

Bob Rieder, Cardiome's chief executive officer, said the company will further review the trial data before deciding on the future of the Oxypurinol program.

Cardiome shares closed at $6.27, down $0.61, or 8.9 percent, in heavy trading on the Nasdaq.

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Kosan delays enrollment in cancer trials; protocols to be amended

Kosan Biosciences Inc. said the National Cancer Institute (NCI) plans to amend the protocols for clinical trials of two Kosan cancer agents after five patients demonstrated electrocardiogram changes without clinically significant consequences following infusion of one of the agents, 17-AAG.

Kosan is developing 17-AAG and a second cancer drug, DMAG, in collaboration with the NCI. According to Kosan, more than 400 patients have already been treated with 17-AAG.

Although the NCI's protocol amendments state that patients currently being treated with either agent may continue to receive treatment, further patient enrollment is being delayed until the protocols and informed consents are modified.

The protocol changes include obtaining ECGs before treatment and after infusion in the initial cycle of therapy. In addition, patients with "certain histories of cardiovascular disease and the use of certain other medications" will be excluded. Further, protocol changes for Kosan-sponsored studies will include appropriate cardiac monitoring.

Protocol amendments are usually implemented within one to three months, Kosan noted.

The firm is currently developing two first-in-class cancer agents, as well as other cancer drugs and treatments for gastrointestinal motility and infectious diseases. All of Kosan's products are in a class of drugs known as polyketides.

Kosan shares closed at $7.35, down $1.51, or 17 percent, in heavy trading on the Nasdaq.

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Pfizer Inc.

Pfizer Inc. purchased all the outstanding shares of Bioren Inc., a private, California-based company that specializes in technology to optimize antibodies. The value of the transaction was not disclosed. Pfizer said such technologies can be used to develop improved treatments with greater efficacy. "The ability to use and develop these technologies will help Pfizer identify new antibody leads as well as improve current antibodies in development," said Nick Saccomano, Pfizer's senior vice president of worldwide research technology.

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Nektar Therapeutics

Nektar Therapeutics entered into a merger agreement with Aerogen Inc. in which Nektar will acquire Aerogen for approximately $32 million. The agreement calls for Nektar to pay approximately $8 million in cash and the balance in stock, although the company does have the option of an all-cash transaction. The merger is expected to be completed before the end of the year. Nektar said the acquisition will not affect its previous 2005 guidance.

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Tercica Inc.

Tercica Inc. said Insmed Inc. filed a Citizen Petition to immediately deny approval of Tercica's New Drug Application for Increlex, an injectable formulation of mecasermin (rDNA origin). According to Tercica, the drug is a potential long-term treatment for children of short stature resulting from a severe deficiency of primary insulin-like growth factor-1, a hormone necessary for statural growth. When Tercica inquired as to the content of the petition, the Food and Drug Administration reportedly told the company this information would be made public "in approximately three days." Tercica said it does not know if the petition will affect the Increlex NDA, which the FDA accepted in May and granted priority review.

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Labopharm Inc.

Labopharm Inc. and Purdue Pharma LP entered into a licensing and distribution agreement whereby Labopharm Europe Ltd. granted Purdue Pharma Products LP exclusive rights to market, sell and distribute Labopharm's tramadol, a once-daily analgesic, in the United States. According to the agreement, Labopharm will receive payments of up to $170 million, including a $20 million up-front licensing fee, a $40 million milestone payment upon approval by the Food and Drug Administration and additional milestone payments based on product sales. Labopharm is also entitled to receive royalties on sales at a rate of 20 percent to 25 percent. Labopharm retains certain co-promotion rights.

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Predix Pharmaceuticals Holdings Inc.

Predix Pharmaceuticals Holdings Inc. initiated an eight-week Phase III trial of PRX-00023, a 5-HT1A agonist intended to treat generalized anxiety disorder with fewer side effects and more convenient dosing than standard therapies. As many as 310 patients are expected to be enrolled in the double-blind, placebo-controlled study, which will evaluate the product's efficacy as measured by a change from baseline in the Hamilton Rating Scale for Anxiety. Predix said preliminary results from a Phase II study of the drug were "encouraging."

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