Biotech Branding

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Celebrex approved for new indication; warning label added

The Food and Drug Administration added a warning label to Pfizer Inc.'s Celebrex (celecoxib) as well as approved the drug to relieve the signs and symptoms associated with ankylosing spondylitis.

The drug is available as a new treatment option for patients with ankylosing spondylitis, a form of arthritis that affects the spine and can strike at a young age, leading to inflammation, stiffness and potentially severe pain.

In addition, the drug's new prescribing information now contains a boxed warning of potential cardiovascular and gastrointestinal risk that can occur in patients taking Celebrex. The change comes after an earlier FDA advisory panel recommended that stronger warnings be added to all selective COX-2 inhibitors; the recommendation also applies to older nonsteroidal anti-inflammatory drugs such as ibuprofen and naproxen.

The new label also advises that Celebrex be prescribed at the lowest effective dose and for the shortest duration of time. For managing ankylosing spondylitis, the company recommends a daily dose of 200 mg, which can be increased to 400 mg/day if no effect is seen after six weeks. If no effect is observed after six weeks of the 400 mg/d dose, Pfizer said a response is not likely and a different therapy should be considered.

Biotech Branding

Studies of Isolagen's contour deformities treatment show mixed results; BLA postponed

Preliminary results from two Phase III trials (Study A and Study B) of Isolagen Inc.'s Isolagen Process, an injectable autologous cellular therapy for the treatment of contour deformities, showed mixed results, prompting the company to postpone its filing of a Biologics License Application. The company's shares dropped 49.2 percent on the news.

In July 2004, the company said it planned to file a BLA as early as the first quarter of 2005. Now, the company anticipates submitting the application sometime in 2006, after the successful completion of an additional trial.

Study A and Study B enrolled approximately 100 patients each; patients were randomized to receive the Isolagen Process or placebo. Primary endpoints for the simultaneous studies were based on blinded physician and patient visual assessments measured by a standardized, six-point photoguide scale and on a blinded patient assessment measured by a 100-point visual analog scale.

Study B demonstrated statistical significance, with positive results on both physician and patient assessments. Study A, however, reflected positive assessment from the patients only.

Results from both studies varied widely from site to site, Isolagen said, with response rates ranging from 7.6 percent to 73.3 percent. Further analysis revealed that injection technique may affect the results.

"Therefore, in November 2005, Isolagen plans to initiate a 100-patient clinical trial with a six-month endpoint, the results of which could be combined with the successful results from Study B to support a BLA filing in 2006," said Dr. Marie Lindner, the company's senior vice president of medical and business affairs. "[O]nly physicians trained in the proper Isolagen injection technique will participate as investigators in this trial."

Shares of Isolagen closed at $2.84, down $2.75, in heavy midday trading on the American Stock Exchange.

Biotech Branding

Abgenix, Amgen's panitumumab receives fast track designation

The Food and Drug Administration granted Abgenix Inc. and Amgen Inc.'s colorectal cancer drug, panitumumab, fast track status.

Panitumumab is "an experimental, fully human monoclonal antibody directed against the epidermal growth factor receptor (EGFr), for patients with metastatic colorectal cancer who have failed standard chemotherapy treatment," according to the companies. While EGFr typically aids in the regulation of cell growth, it can also cause cancer cells to grow. When proteins bind to EGFr that exists on the surface of tumor cells, changes in the EGFr trigger signals that stimulate growth of the tumor cells. Panitumumab interferes with this process by preventing the proteins from binding to the EGFr.

The companies said they are working toward submitting a Biologics License Application for panitumumab by the end of the year, noting that this time frame could extend into the first quarter of 2006. The drug is being assessed as a monotherapy and in combination with other agents to treat various types of cancer, including colorectal, lung and kidney cancer.

Shares of Amgen closed at $81.63, up $1.86, or 2.3 percent, in moderate Nasdaq trading.

Biotech Branding

BioMarin files NDA for new form of Orapred

BioMarin Pharmaceutical Inc. filed a New Drug Application for Orapred ODT (prednisolone sodium phosphate) orally disintegrating tablets, a new formulation of Orapred, which is a liquid steroid commonly used to reduce inflammation in conditions such as asthma, arthritis and cancer.

If approved, Orapred ODT would be the first orally disintegrating tablet form of prednisolone on the market, BioMarin said.

The taste of the drug is masked in the orally disintegrating tablet, and it requires no refrigeration.

"Orapred ODT holds the potential to provide individuals of all ages with a new formulation of prednisolone that is convenient and easy to administer," said Jean-Jacques Bienaime, chief executive officer of BioMarin. "We are committed to maximizing the value of our Orapred franchise and expect to have Orapred ODT on the market in mid-2006, pending regulatory approval."

Biotech Branding

CollaGenex submits NDA for Oracea rosacea treatment

CollaGenex Pharmaceuticals Inc. submitted a New Drug Application for Oracea (doxycycline) to treat patients with rosacea.

Oracea would be the first orally administered, systemic treatment for rosacea, according to CollaGenex.

The NDA included data from two Phase III studies involving a total of 537 patients who were given Oracea or placebo once daily for 16 weeks. The trials met their primary endpoint of showing a greater reduction in inflammatory lesions from baseline in patients treated with Oracea as compared with patients who received placebo.

The Oracea groups in the two trials experienced a mean reduction in inflammatory lesions at the rate of 61 percent and 46 percent; the placebo groups experienced mean reductions of 29 percent and 20 percent.

CollaGenex's chief executive officer, Colin Stewart, said the company anticipates a 12-month review period followed by a product launch in the third quarter of next year.

"[W]e believe that the availability of a convenient, safe and effective product will significantly expand the current $500 million market for prescription drugs to treat this potentially disfiguring condition," Stewart said.

Biotech Branding

Large Scale Biology's potential treatment for lysosomal acid lipase disorder granted orphan drug status

Large Scale Biology Corp. (LSBC)'s recombinant human lysosomal acid lipase (LAL) treatment received an orphan drug designation from the Food and Drug Administration, less than three months after the company submitted its application.

LAL, a natural human enzyme, plays a role in the metabolism of specific lipids. A lack of this enzyme, which often results from a genetic disorder, can cause or exacerbate certain diseases and lead to serious or even fatal accumulations of lipids in major organs.

On a broader scale, the firm said the product could be useful for treating arterial lipid plaque deposits, possibly eliminating the need for surgery or other interventions, noting that these deposits occur in a "substantially" larger number of patients than do genetic disorders in LAL synthesis or regulation.

LSBC obtained exclusive, worldwide rights to all uses of the LAL product from the Cincinnati Children's Hospital Medical Center. The two groups are currently collaborating on the preclinical development of the treatment, which LSBC manufactures using its plant-based production system.

Biotech Branding

Biotech Branding
Abbott

Abbott's co-promotion agreement with Boehringer Ingelheim Pharmaceuticals Inc. for three drugs has expired. Abbott will cease its U.S. distribution of Mobic (meloxicam), a pain drug, and Flomax (tamsulosin hydrochloride), a treatment for enlarged prostates, as of Jan. 1, 2006, but will continue to co-promote Micardis (telmisartan), a blood pressure treatment, through the end of March. In 1999, the companies entered into the co-promotion agreement that appointed Abbott as Boehringer's distributor and co-promoter of the three drugs in the United States. Abbott will no longer record the sales of these drugs, but will continue to earn a commission based upon U.S. sales of the drugs.

Biotech Branding

Biotech Branding
Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.'s net income for the second quarter of 2005 rose 5 percent to $241.2 million. Earnings per diluted share for the quarter rose 6 percent to $0.36, and net sales grew 4 percent to $1.23 billion. Teva said that higher sales in all of the company's other major operations helped to offset lower sales in its U.S. generic operations, which were stifled by increased competition and fewer opportunities to launch new products.

Biotech Branding

Biotech Branding
Guidant Corp.

Guidant Corp. received approval from the Food and Drug Administration to relaunch its Contak Renewal 3 cardiac resynchronization therapy defibrillators throughout the United States. The company found a new component solution that resolves safety concerns related to a magnetic switch in the defibrillators; these concerns prompted Guidant to pull the product from the market in June. The agency also approved U.S. distribution of software that will enable physicians to better manage patients who had the earlier devices implanted. Guidant expects to resume worldwide distribution of the defibrillators by midweek and to achieve full product supply by the end of the month.

Biotech Branding

Biotech Branding
Discovery Laboratories Inc.

Discovery Laboratories Inc. responded to an approvable letter from the Food and Drug Administration for Surfaxin (lucinactant), a respiratory distress syndrome prevention therapy for premature infants. The company believes its response provides the additional information the FDA requested to complete a review of the New Drug Application. Concerns noted in the original approvable letter from the FDA, sent in February, included issues pertaining to the product's labeling, chemistry and commercial production; the agency did not request additional preclinical or clinical studies. Pending approval, Discovery hopes to launch Surfaxin in the first quarter of next year.

Biotech Branding