Pharma Sector: Few Newsmakers Of The Week - Synta, Glaxo, Merck, Wyeth, Lilly, Medicis, Pipex

Add as your preferred news source on Google

Add Now

The first month of the New Year is already over. Here's what happened on the pharma turf in the week ended Feb.1, 2008.

With the incidence of melanoma rising more rapidly than any other cancer during the past ten years, there is an urgent need to develop new therapies in order to curb the increase in melanoma death rate. There are currently few treatment options for advanced melanoma, and none that can improve overall survival beyond the median 6 to 9 months. Elesclomol, which is being jointly developed by Synta and Glaxo - the first in a new class of cancer therapies called oxidative stress inducers, which kills only tumor cells is expected to have a major impact on the treatment of metastatic melanoma.

Merck's bit of good tidings this week was the FDA approval for the injectable version of its anti-nausea pill EMEND. Chemotherapy induced nausea and vomiting are two of the most distressing and feared toxicities of cancer treatment. The market for drugs to treat chemotherapy-induced nausea and vomiting is rather small, around $1.5 billion, which means Merck is not going to benefit much, even with the new formulation of its already approved anti-nausea drug. Merck's other seven products in its pipeline, which are in late stage development, target diseases with a large potential market.

On concerns of a generic threat to its blockbuster heartburn drug Protonix, as Wyeth failed to reach an agreement with Teva, shares of Wyeth took a hit on Wednesday falling near a three-year low to $39.25. Though the launch of the authorized generic version of Protonix could save revenue for Wyeth, which would be grabbed by the first ANDA (abbreviated new drug application) filer company, Bear Stearns analyst John Boris has only a modest sales estimate for Protonix, this year. Including the authorized generic version, the analyst expects Protonix to generate sales of $350 million for Wyeth.

According to business intelligence firm Cutting Edge Information, 21% of pharmaceutical licensing deals stem from existing relationships between companies, benefiting both companies more than their individual attempts to bring new drugs to market. Statistics have also shown that fewer than 10% of the compounds developed under the biotech-pharma licensing deals turn into market-place reality. This week, Danish biopharma company Gastrotech Pharma signed a licensing deal with Eli Lilly for the development of GTP-010 for Irritable Bowel Syndrome and Functional Dyspepsia.

With the FDA deeming Medicis' biological license application for Reloxin an incomplete one, Allergan, the maker of Botox - the only FDA approved antiwrinkle therapy will continue to dominate the U.S. market for botulinum toxins as there is going to be a further delay in the launch of Reloxin. Other firms' cosmetic botulinum toxin development programs lag well behind Reloxin. The launch of Reloxin would have increased competition and reduced prices for cosmetic botulinum toxin. According to reports, patients pay an estimated $500 for Botox injections, which reportedly last for about four months.

CLINICAL TRIALS

Well On Track - Myriad Genetics Completes Early Stage Trial Of Investigational Direct Thrombin Inhibitor

Tuesday, Myriad Genetics Inc. (MYGN) announced that it completed a Phase 1 human clinical trial of MPC-0920, an orally available, blood thinner or direct thrombin inhibitor.

The market to treat thrombosis is large, totaling over $6.5 billion in the United States last year, and there is an urgent need for improved drugs, particularly those that can be taken orally.

Thrombosis, the formation of a clot within a blood vessel, is one of the most common causes of death in the Western World. Some people suffer a clot in their legs, a condition called deep vein thrombosis or in their lungs, which is called pulmonary embolism. The drugs currently used to treat thrombosis are the anticoagulants - Heparin and Warfarin.

Myriad Genetics' Phase 1 trial enrolled healthy volunteers in a single, escalating dose format. The primary objectives of the Phase I trial were to examine the safety and pharmacokinetics of MPC-0920 and a secondary objective was to study the biological activity of MPC-0920. The results demonstrated significant biological effect on clotting time in the subjects studied and a desirable safety profile following oral administration. The antithrombotic market is valued at US$ 9.6 billion and has two blockbusters - Sanofi-Aventis' Lovenox and Bristol-Myers' Plavix.

It is interesting to note that Myriad Genetics, which has no debt and sufficient liquidity to carry out research and development, is seeking a commercial partner to co-develop and further progress the development of MPC-0920, rather than pursuing further regulatory development independently.

Myriad has lost over 28% of its stock value since hitting a high of $58.83 on October 8, 2007.

FDA/REGULATORY APPROVALS

More Than Skin Deep - Synta, Glaxo Investigational Skin Cancer Drug Gets Orphan Drug Status

Elesclomol, an investigational drug for treating advanced melanoma, which is being developed under a global collaboration agreement between Synta Pharmaceuticals Corp. (SNTA) and Glaxosmithkline plc (GSK), has been granted orphan drug designation by the FDA, the companies announced on Monday.

Orphan drug status is designed to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases, which affect fewer than 200,000 people in the United States.

Elesclomol has not been approved for any indication in any market. In November 2006, Elesclomol received Fast Track designation from the FDA. A recent study led by Dr. Steven O'Day of The Angeles Clinic and Research Institute, showed that treatment with Elesclomol in addition to chemotherapy, more than doubled the amount of time patients survived without progression of their cancer. The current treatment options improve overall survival only up to a median 6 to 9 months.

Currently, Elesclomol is in a Phase 3 clinical trial, in which it is being evaluated in combination with chemotherapy drug paclitaxel in metastatic melanoma.

According to the American Cancer Society, melanoma, commonly known as skin cancer accounts for about 5% of all skin cancers but causes about 75% of all skin cancer-related deaths. An estimated 60,000 people will be diagnosed and nearly 8,200 people will die from melanoma this year in the U.S. alone.

Elesclomol is a further addition to Glaxo's late stage oncology pipeline, which currently includes 10 Phase 3 programs. Glaxo licensed Synta's Elesclomol in October of 2007 by paying an upfront fee of $80 million. Synta is also entitled to receive another $885 million in potential milestone payments later.

Founded in July 2001, Synta went public in February of 2007 offering shares at $10 each and since then, the stock has lost 32% of its value. Apart from Elesclomol, Synta's pipeline includes 4 small molecule drug candidates targeting cancer and inflammatory diseases.

Good Shot? - Merck's Injectable Version Of Anti-nausea Pill Gets FDA Approval

Tuesday, drug giant Merck & Co., Inc. (MRK) announced that its injectable version of anti-nausea pill EMEND, a new intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting was approved by the FDA.

EMEND (fosaprepitant dimeglumine) for Injection is an intravenous prodrug of the oral formulation of EMEND (aprepitant). The oral formulation of EMEND is used to help prevent nausea and vomiting following surgery or, when used in combination with other antiemetics, it is used to help prevent nausea and vomiting caused by chemotherapy.

Merck said its injectable version of EMEND 115 mg provides a new option for patients receiving an antiemetic on the first day of their chemotherapy. EMEND for Injection may be substituted for the 125 mg oral capsule of EMEND on the first day.

When EMEND for Injection is administered, fosaprepitant is rapidly converted in the body to aprepitant. EMEND for Injection is approved for use in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting.

Merck stated that EMEND for Injection and oral EMEND, when used in combination with other antiemetics, are only used to help prevent nausea and vomiting caused by chemotherapy. The drugs are not used to treat nausea and vomiting after they start.

Safety First - FDA Slams Pipex Pharma's Coprexa For Wilson's Disease

Tuesday, Pipex Pharmaceuticals Inc. (PP) announced that its new drug application for its lead anti-copper drug candidate Coprexa for Wilson's disease, a genetic metabolic disorder was rejected by the FDA. The regulatory agency has requested an additional safety study.

Among the issues raised by the FDA in its refusal to file, communicated to Pipex are the adequacy of the analytical methodology to characterize the active pharmaceutical ingredient of Coprexa; a request to conduct an additional short term reproductive drug safety study in animals; four formatting and presentation items contained in the NDA; and two preliminary assessments concerning the adequacy of the clinical evidence of safety and efficacy of Coprexa.

Pipex said the clinical and nonclinical deficiencies cited by the FDA were already discussed, resolved and agreed upon with the FDA during one of the two pre-NDA meetings held with a first review division of the FDA in August of last year. According to the FDA, Pipex's application was reviewed by a medical group in the new review division, which had expertise in diseases resulting from inborn metabolic errors. Pipex believes that FDA's subsequent transfer of review groups might have resulted in a loss of continuity of discussion, leading to the regulatory agency's decision to deny further review of the application. Pipex plans to meet with the FDA within 30 days to resolve the issue.

Coprexa is also being tested for other indications. The company initiated a mid-stage study of Coprexa for the treatment of Alzheimer's disease in mid-January.

The company's clinical development stable includes Trimesta, a drug targeted at multiple sclerosis, Oral Z-monocys for dry age-related macular degeneration and Effirma, a treatment for fibromyalgia syndrome.

A Cosmetic Denial - FDA Rejects Medicis Pharma's Application For Antiwrinke Treatment Reloxin

Thursday, Medicis Pharmaceutical Corp. (MRX) announced that its biological license application or BLA for antiwrinke treatment Reloxin, a botulinum toxin type A was rejected by the FDA, deeming it an incomplete one. Allergan Inc.'s (AGN) Botox dominates the U.S. market for botulinum toxins and is the only FDA approved product to treat facial wrinkles.

The regulatory agency has raised doubt about how Medicis would fulfill its responsibilities as the manufacturer of the product. The FDA has also pointed out that the application included letters of authorization supporting a separate BLA submitted by French drug company Ipsen.

Medicis noted that the FDA has only addressed administrative deficiencies in the application and did not reference any substantive deficiencies. Meanwhile, JP Morgan analyst Adam Greene lowered his rating on Medicis to "neutral" from "overweight", following the FDA's action.

In 2005, Ipsen sold U.S., Canadian and Japanese rights to Reloxin, its botulinum toxin type A developed for cosmetic surgery, to Medicis. Ipsen bought the rights back from Inamed in 2005, which was being acquired by Allergan. In 2002, Inamed had acquired the U.S. rights to Reloxin, from Ipsen.

Medicis, which believes its application is strong, said it would continue to work with the FDA. With the FDA rejecting its biological license application for Reloxin, the product is not likely to be launched until next year.

Following the regulatory setback, Medicis' shares tumbled 6.5% to close Thursday's trade at $20.38 while Allergan shares rose over 4% to $67.08.

DEALS/ AGREEMENTS

Heartburn For.. - Wyeth Launches Authorized Generic Version Of Its Own Protonix; Standstill Agreement With Teva Becomes Void

Having failed to reach a settlement in the ongoing litigation related to heartburn drug Protonix with generic drug firm Teva Pharmaceutical Industries Ltd. (TEVA) on Tuesday Wyeth (WYE) and its business partner, Nycomed announced the U.S. launch of Wyeth's own generic version of its branded heartburn drug Protonix. In 2007, Protonix raked in $1.91 billion in sales, representing an increase of 6% over 2006. Protonix's patent is set to expire in July 2010 and can be extended for further six months if Wyeth seeks a pediatric use for the drug.

In August of 2007, Teva was given the 180-day market exclusivity for 20 mg and 40 mg versions of generic Protonix, being the first to seek approval for generic Protonix. Sun Pharma had also filed its abbreviated new drug application for generic version of Protonix.

Following Wyeth seeking preliminary injunction to halt sales of Teva's generic version of Protonix, the final FDA approval for Teva's generic Protonix was stayed until Aug. 2, 2007. Teva also agreed not to launch generic Protonix before Sept. 7, 2007. But on Sep.7, 2007, a federal Judge in New Jersey denied Wyeth's motion for a preliminary injunction against Teva.

Meanwhile, Teva launched the drug in the U.S on December 24, 2007. Simultaneously Teva entered into a standstill agreement with Wyeth and agreed not to ship additional product for a period of 30 days. Following the expiry of the standstill period on Jan 22, 2008, Wyeth and Teva agreed to further extend the standstill period through January 31, 2008, hoping to reach a settlement.

According to agreement between the two companies, the standstill would cease if Wyeth begins sale of a generic version of Protonix. And now that Wyeth has launched the generic version of Protonix, the standstill agreement has become void. Although Teva has announced it has no immediate plans to resume additional shipments of generic Protonix, with Sun Pharma yet another company which was given the go-ahead to launch generic Protonix, launching the drug on Jan.30, will Teva hold back?

The legal dispute is far from over as Wyeth has decided to vigorously pursue its litigation against Teva and other infringing generics. The company said it would continue to seek an injunction against any infringement of the patent covering Protonix as well as monetary damages, including lost profits, from Teva.

This is not the first time Wyeth and Teva are embroiled in a patent infringement suit. Earlier, the two companies were battling over the patent for antidepressant Effexor, Wyeth's top-selling drug. But even before the trial began, Wyeth entered into a settlement with Teva by agreeing to slice a few years off its patent covering Effexor. Wyeth agreed to allow Teva to sell generic Effexor XR, the extended release version of the drug, in 2010, seven years ahead of its patent expiration. In return, Teva agreed to pay Wyeth a percentage of profits from sales of generic Effexor.

Right Move - Gastrotech Pharma Signs In-licensing Deal With Lilly For Irritable Bowel Syndrome Drug

Following positive clinical data of investigational compound for Irritable Bowel Syndrome, Danish company Gastrotech Pharma on Monday announced it has signed an agreement with Eli Lilly & Co. (LLY) to in-license the experimental drug, now named GTP-010, an analogue of the naturally occurring intestinal hormone GLP-1.

The proof of concept study to assess pain reduction associated with Irritable Bowel Syndrome was conducted jointly by Lilly and Gastrotech. Gastrotech now plans to develop GTP-010 to treat Irritable Bowel Syndrome. The study met the primary clinical endpoint finding that GTP-010 was able to reduce pain by greater than 50% of the maximum total possible pain relief.

GTP-010 is an analogue of GLP-1, a naturally occurring intestinal hormone that plays an important physiological role in assisting the human body to maintain appropriate blood sugar levels and modulate gastric motility following meals.

Under the terms of the licensing agreement, Gastrotech will receive a global exclusive licence to develop and market GTP-010 for Irritable Bowel Syndrome and Functional Dyspepsia. Lilly will take an equity stake in Gastrotech and will receive royalties on sales.

In March 2004, Gastrotech entered into a collaboration agreement with Eli Lilly to continue the development of proprietary peptides that treat irritable bowel syndrome and functional dyspepsia. While Gastrotech undertook to continue the ongoing double-blind, placebo-controlled clinical Phase II trial of a glucagon-like peptide-1 or GLP-1 analogue in Irritable Bowel Syndrome patients with moderate to severe pain, Lilly took over the responsibility of manufacturing the clinical compound.

With some of the popular drugs for irritable bowel syndrome and constipation like Lotronex manufactured by Glaxo and Zelnorm manufactured by Novartis, pulled off the U.S. market due to safety concerns, the market for Irritable Bowel Syndrome drugs is believed to be a potentially profitable one, which is open for the taking.

For comments and feedback contact: editorial@rttnews.com