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GSK possible candidate to acquire Boots' OTC health care unit, sources say

GlaxoSmithKline Plc is being tabbed as one of the companies most likely to acquire the over-the-counter health care unit of retailer Boots Group Plc in a sale that could be worth more than $2.17 billion, Reuters reported, attributing the speculation to "sources close to the sale."

"Glaxo is keen to expand its OTC franchise, and Boots is a good fit," one of the unidentified sources told Reuters. "There are plenty of synergies, since Boots is a U.K.-based business."

According to these sources, GSK, Bayer AG, Pfizer Inc. and Reckitt Benckiser Plc, a maker of household cleaning products, were all "shortlisted to go through to the next round of bidding."

Other press reports mentioned that Novartis AG might also be on the shortlist of bidders, Reuters noted, adding that "it was not immediately clear if the Swiss drugmaker had made it through to the second round."

Bidders that have been shortlisted will be able to hold meetings with Boots' management and will have access to the OTC unit's books, sources told Reuters.

"We expect quite a long period of due diligence before second-round bids to go in," another source commented. The bid deadline is expected to be set "toward the end of September," according to a third source.

Boots Healthcare International markets Nurofen painkillers, Strepsils throat lozenges and Clearasil skin care products.

Reuters reported that Boots will focus on its core retail business after selling the OTC unit, a transaction Boots hopes to conclude by year-end.

At GSK's annual meeting in May, Chief Executive Officer Jean-Pierre Garnier told shareholders "he would look at the Boots opportunity," Reuters said, adding that many "industry observers" believe GSK will win the bid.

Goldman Sachs is in charge of the auction.

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Merck's Singulair receives additional indication for indoor allergies

Merck & Co. Inc. received approval from the Food and Drug Administration for Singulair (montelukast sodium) to treat the symptoms of perennial allergic rhinitis, or indoor allergies, in adults and children aged 6 months or older.

In a placebo-controlled clinical trial, Singulair improved daytime nasal symptoms, including nasal congestion, runny nose, nasal itching and sneezing, and had a safety profile similar to that of placebo, Merck said.

"Allergic rhinitis is one of the most common allergic conditions today, with approximately 50 million people in the United States suffering some form of the condition," said Dr. Gailen Marshall Jr., director of the University of Mississippi Medical Center's division of clinical immunology and allergy. "Experts have estimated that 55 to 80 percent of these patients suffer from perennial, or year-round, allergic rhinitis, which is commonly triggered by indoor allergens such as dust, pet dander or mold."

The drug, which was approved in 2003 to treat the symptoms of seasonal allergic rhinitis, blocks leukotrienes rather than blocking histamine, as do most oral allergy drugs. Singulair is the only drug indicated for allergic rhinitis "that specifically targets this particular underlying contributor to allergy symptoms," according to Merck.

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Barr's subsidiary receives approvable letter for extended-cycle oral contraceptive, Seasonique

Barr Pharmaceuticals Inc. confirmed that its subsidiary Duramed Pharmaceuticals Inc. received an approvable letter from the Food and Drug Administration regarding the New Drug Application for Seasonique (levonorgestrel/ethinyl estradiol 0.15 mg/0.03 mg and ethinyl estradiol 0.01 mg) extended-cycle oral contraceptive tablets.

The FDA requested in the letter that Duramed provide additional data to support Seasonique's regimen of 84 days of combination therapy followed by seven days of unopposed estrogen. The extended regimen is intended to reduce the number of withdrawal bleeding periods from monthly to four per year.

Data used to support the NDA were derived from two U.S. clinical trials involving approximately 2,500 women aged 18 to 40 years. An extension study is still in process.

"We intend to seek a meeting with the agency within the next 30 days to discuss our ongoing studies of Seasonique and how they might satisfy [the] FDA's request for additional information," said Bruce Downey, Barr's chief executive officer. "We are confident that we can provide the information requested in the agency's approvable letter."

Barr launched its other extended-cycle oral contraceptive, Seasonale, in 2003 and currently has an NDA pending with the FDA for a lower dosage formulation of the product. The company said more than 1 million prescriptions have been written for Seasonale.

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Ariad's tumor compound, AP23573, receives orphan drug designation

Ariad Pharmaceuticals Inc. said its novel mammalian target of rapamycin (mTOR) inhibitor, AP23573, received orphan drug designation from the Food and Drug Administration as a treatment for soft-tissue and bone sarcomas.

The small molecule drug starves cancer cells and shrinks tumors by inhibiting mTOR, a critical cell-signaling protein that regulates the response of tumor cells to nutrients and growth factors and controls tumor blood supply and blood vessel growth, the company said. The drug also blocks the proliferation and migration of vascular smooth muscle cells.

"In the absence of any effective treatments for advanced soft-tissue sarcomas or refractory bone sarcomas that have spread, the orphan drug designations for AP23573 provided by the FDA should help us address this unmet medical need more effectively," said Dr. Harvey Berger, Ariad's chief executive officer. "We are working with key regulatory agencies to advance AP23573 toward its initial registration trial and subsequent regulatory submissions for marketing authorization in these devastating cancers."

The designation could provide Ariad with benefits such as funding for clinical studies, study-design assistance, a waiver of Prescription Drug User Fee Act fees, tax credits and up to seven years of market exclusivity upon regulatory approval of the product.

The drug was granted fast track status in April and is currently being studied in Phase I and Phase II trials in patients with solid tumors and hematologic cancers.

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Myogen reports positive data from hypertension trial; shares jump

Myogen Inc. released positive results from a Phase IIb trial of darusentan, a potential treatment for resistant hypertension, pushing shares of the company up 60 percent.

In the study, researchers randomized 115 patients to receive titrated doses of darusentan or placebo for 10 weeks until they reached the target dose of 300 mg/day. Patients were then followed for a two-week drug withdrawal period.

At baseline, all patients had a systolic blood pressure of at least 140 mmHg and a diastolic blood pressure of at least 90 mmHg, despite taking three other drugs for hypertension.

Results showed that 300 mg/d of darusentan statistically significantly reduced systolic blood pressure by 11.6 mmHg and diastolic blood pressure by 7.0 mmHg. The company said lower doses of the drug at earlier time points also produced clinically meaningful reductions in systolic and diastolic blood pressure.

Darusentan was generally well tolerated, and no serum aminotransferase concentrations were observed that were more than twice the upper limit of the normal range, according to Myogen. Based on these data, the company said it will proceed with Phase III development of the drug.

"As an endothelin receptor antagonist, darusentan affects blood pressure through a mechanism of action different than those of currently approved antihypertensive drugs," said J. William Freytag, Myogen's chief executive officer. "The results of this trial indicate darusentan could provide additional blood pressure lowering benefit in this patient population."

Myogen shares closed at $21.67, up $8.13, in heavy trading on the Nasdaq.

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Genelabs' Prestara maintains bone mineral density in open-label trial

A preliminary analysis of an open-label trial dubbed GL03-01 revealed that Genelabs Technologies Inc.'s Prestara (prasterone) met the primary endpoint of maintaining bone mineral density (BMD) in women with systemic lupus erythematosus. News of the results pushed shares of the firm up 16.3 percent.

After Prestara failed to provide a statistically significant benefit in the six-month, double-blinded, placebo-controlled GL02-01 study, patients who completed the trial were enrolled in GL03-01, a 12-month follow-on trial. In the second trial, 115 women with SLE who were taking glucocorticoids were randomized to receive Prestara 100 mg/day or 200 mg/d.

In the course of the 12 months, patients who received Prestara 200 mg showed an approximate 0.9 percent increase in BMD at the lumbar spine. In addition, Genelabs said that patients who received Prestara 200 mg during both trials "experienced an increase in BMD at the lumbar spine over each successive six-month interval in the 18-month duration of the combined studies."

However, patients who received Prestara 100 mg actually lost a measurable amount of BMD at the lumbar spine during the 12-month period.

While Genelabs said the studies provide useful data on the positive effect of Prestara, it also noted that the Food and Drug Administration typically does not consider open-label studies sufficient to support a drug's approval. The company mentioned that it is scheduled to meet with the regulatory agency to discuss options for proceeding with Prestara.

"[I]n determining our future development plans, we must weigh these benefits against the standard required by the FDA for approval of this investigational drug. Our analyses of these study results are continuing; however, we expect to be able to submit them to the FDA in advance of an upcoming meeting, which we hope will provide additional clarity on what may be needed going forward," the firm explained.

In an earlier Phase III trial designated as GL95-02, Prestara significantly increased BMD compared with placebo. After the conclusion of this trial, the FDA sent the company an approvable letter in August of 2002 requesting the successful completion of an additional trial. GL02-01 was conducted to satisfy the FDA's requirement, but the results did not statistically significantly favor Prestara.

Shares of Genelabs closed at $0.57, up $0.08, in heavy trading on the Nasdaq.

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GlaxoSmithKline Plc

GlaxoSmithKline Plc and Human Genome Sciences Inc. will jointly develop and commercialize HGS-ETR1 (mapatumumab), a human monoclonal antibody that binds specifically to the TRAIL receptor 1 protein. The compound, which is considered an agonistic antibody, induces apoptosis, or cell death, in human cancer cell lines expressing TRAIL receptor 1 and has antitumor activity in a broad range of tumor types, by itself and in combination with chemotherapy, according to Human Genome Sciences. GSK exercised its option to collaborate on the drug as part of a 1996 agreement between the two companies; they will split the cost of developing the drug, as well as potential sales and marketing expenses and profits.

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Novartis AG

Novartis AG acquired global rights from SeBo GmbH to develop, manufacture and commercialize an investigational oral phosphate binder intended to treat patients with chronic kidney disease and patients who are already on dialysis. The compound, which is in Phase I development, is being developed to treat hyperphosphatemia, or elevated serum phosphate levels, in patients with late- or end-stage renal disease. Financial terms of the agreement were not disclosed. Novartis said that existing hyperphosphatemia treatments "do not reliably achieve treatment standards set by kidney specialists to help patients effectively manage their disease."

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Serono Inc.

Serono Inc. and Genmab A/S entered into an agreement in which Serono received exclusive worldwide rights to develop and commercialize Genmab's HuMax-CD4, a fully human monoclonal antibody in development for the treatment of cutaneous and noncutaneous T-cell lymphoma (CTCL and NCTCL). The compound, which was granted fast track designation, is currently being evaluated in a Phase III clinical trial for CTCL under the Food and Drug Administration's special protocol assessment process. As per the agreement, Genmab will receive a $20 million license fee and Serono will invest $50 million in Genmab common stock at a premium to the market price. Genmab could eventually receive as much as $215 million, including milestone payments and royalties, as a result of the agreement.

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Anadys Pharmaceuticals Inc.

Anadys Pharmaceuticals Inc.'s Investigational New Drug application for ANA975, an oral prodrug of isatoribine, was accepted by the Food and Drug Administration. The acceptance triggers a $10 million milestone payment from Novartis AG. The two companies are collaborating to develop and commercialize the drug, a toll-like receptor 7 agonist intended to treat patients with chronic hepatitis C virus infections. Anadys said it is looking forward to beginning U.S. clinical trials of the drug to complement trials already under way in the United Kingdom.

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