Momenta shares rise on biosimilars deal with Baxter

Momenta shares rise on biosimilars deal with Baxter

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(Global Markets) - Shares of Momenta Pharmaceuticals (MNTA.O) rose as much as 7 percent early Friday, a day after it inked a deal with Baxter International Inc (BAX.N), marking the third partnership on generic versions of biotechnology drugs this month.

Momenta will receive an upfront payment of $33 million from Baxter for developing up to six biosimilars, and is entitled to additional milestone payments.

The deal also includes Momenta receiving royalties with a profit-share option on four drugs, for which Baxter will cover clinical trials, manufacturing and commercialization, according to Canaccord Genuity analyst Ritu Baral.

The analyst, who has a price target of $23 on Momenta stock, reiterated her "buy" rating.

Momenta and Baxter's deal comes just days after Amgen Inc (AMGN.O) and generic drugmaker Watson Pharmaceuticals Inc (WPI.N) announced a partnership to develop and sell biosimilars of cancer drugs.

Earlier in the month, Samsung announced an agreement with biotechnology company Biogen Idec (BIIB.O) to set up a joint venture for developing, manufacturing and marketing biosimilars.

Biosimilars are copies of existing biotechnology products developed from organic compounds. However, due to the complex nature of these compounds, biosimilars have come under the regulatory scanner.

Companies hoping to cash in on a potential multi-billion dollar market for biosimilars have long awaited guidelines from the U.S. Food and Drug Administration on the development of such drugs.

Analyst Baral said the slew of deals on biosimilars follows increased FDA clarity on the regulatory path.

Shares of Cambridge, Massachusetts-based Momenta were up 4 percent at $17.63 on Friday morning on Nasdaq.

(Reporting by Zeba Siddiqui in Bangalore; Editing by Roshni Menon)

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Mannkind up on FDA nod for diabetes device trials

Mannkind up on FDA nod for diabetes device trials

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(Global Markets) - Shares of MannKind Corp (MNKD.O) rose as much as 33 percent on Friday, a day after the company said U.S. regulators cleared the design of two clinical studies to test the efficacy and safety of its experimental device, Afrezza, to treat diabetes.

In January, the U.S. Food and Drug Administration rejected the inhaler and asked the company for two more trials to prove that a second-generation version of the device, known as the Dreamboat, is equivalent to a first-generation inhaler known as MedTone.

The FDA confirmed protocols for two studies in which the device will be tested on patients with type 1 and type 2 diabetes.

"We are especially encouraged by the regulatory progress of the Type 2 trial, which we believe now enables approval with a label to address a broader, earlier stage disease, patient population than we had previously anticipated," JMP Securities analysts said in a note to client.

JMP upgraded Mannkind's stock to "market outperform" and set a price target of $7.

Afrezza is administered at the start of a meal and dissolves immediately upon inhalation to deliver insulin to the blood stream.

The trials, called Study 171 and Study 174, will assess the effectiveness of Afrezza in bringing down glucose level in blood compared with MedTone. Mannkind had earlier said that they do not expect the trials to be completed by 2012.

"Ultimately this could be an excess of a billion dollar drug, but how quickly it gets to the market is a real question. It is not going to be in the market for two years," CRT Capital Group analyst Liah Hartman told Global Markets.

The company might be able to complete trials by the late fourth quarter of 2012 or first quarter of 2013, analyst Hartman added.

However, there are concerns over the company raising enough capital to fund the trials.

"It is very possible that they could partner globally for these trials ... Chief Executive Alfred Mann could personally increase the size of unsecured credit which he has been providing the company lately," Hartman said.

Shares of the Valencia, California-based company were up 23 percent at $2.91 on Friday on Nasdaq. They closed at $2.37 on Thursday on Nasdaq.

(Reporting by Kavyanjali Kaushik in Bangalore; Editing by Saumyadeb Chakrabarty, Roshni Menon)

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FDA chides Novartis on meningitis vaccine promotion

FDA chides Novartis on meningitis vaccine promotion

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WASHINGTON (Global Markets) - Novartis AG falsely implied that its Menveo meningitis vaccine was approved in a manner consistent with guidelines from an influential U.S. advisory group, health regulators said in a letter to the Swiss drugmaker.

The U.S. Food and Drug Administration in the letter dated June 24 and released on Friday said some statements in a recorded phone call and professional slides from March were "false and misleading."

The FDA also said the promotional materials falsely imply that FDA-approved use of Menveo is consistent with published recommendations by the U.S. Advisory Committee on Immunization Practices, a panel of federal vaccine experts that advises the U.S. Centers for Disease Control and Prevention.

The FDA requested that Novartis immediately stop using such promotional material and the company's spokeswoman said the vaccine unit has already done that.

"(The unit) takes this communication very seriously and has immediately ceased the dissemination of the material in question," said spokeswoman Brandi Robinson. "We are committed to addressing the FDA's concerns adequately and expeditiously."

Earlier this month, the FDA accepted Novartis's application to broaden the use of Menveo in infants and toddlers from 2 months of age. The vaccine, which protects against strains of the meningococcal disease that causes potentially deadly meningitis, is approved in the United States for people aged between 2 and 55.

Novartis has three types of meningitis vaccines, and it is optimistic that its meningitis franchise will be a blockbuster. The company is also hoping its meningitis franchise will help the unit reduce its dependency on sales from pandemic vaccines.

The FDA posted the warning letter here: here

(Reporting by Alina Selyukh. Editing by Robert MacMillan, Bernard Orr)

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FDA clears new Merck drug for hepatitis C

FDA clears new Merck drug for hepatitis C

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WASHINGTON/NEW YORK (Global Markets) - Merck & Co (MRK.N) won U.S. approval on Friday to sell a new drug considered a major advance against the liver-destroying hepatitis C virus.

Victrelis is expected to help transform treatment of the potentially fatal disease with higher cure rates and shorter courses of therapy for some patients.

A similar medicine from Vertex Pharmaceuticals Inc (VRTX.O) is poised to win FDA clearance later this month. Industry analysts predict sales of more than $1 billion annually for each drug with the Vertex product dominating the market.

Merck shares rose 0.6 percent in after-hours trading to $37.33, up from their $37.08 close on the New York Stock Exchange. Approval of Victrelis was widely expected after a Food and Drug Administration advisory panel recommended the drug in an 18-0 vote in April.

Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new medicines, which still must be taken in combination with older hepatitis drugs. About 170 million people around the world are infected with hepatitis C.

"There are so many patients who are just waiting for a new treatment option. There hasn't been anything new in 10 years," said Dr. Eliav Barr, Merck's head of infectious diseases research.

"We're just thrilled and can't wait to get the medicine out the door to patients," Barr said, adding that Merck was ready to begin shipping the drug within the week.

The cure rate for Victrelis reached 66 percent in Merck's studies, an improvement over the 35 to 40 percent seen with current drugs, but less than the 79 percent reported for newly treated patients given the Vertex drug, telaprevir.

"Victrelis is an important new advance for patients with hepatitis C," Dr. Edward Cox, head of the FDA office of antimicrobial products, said in a statement.

The FDA approved Victrelis for adults with hepatitis C who were never treated or who failed previous treatments.

In the United States, 3.2 million people have hepatitis C, a blood-borne disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. The disease is the leading cause of liver transplants in the U.S.

Both the Merck and Vertex medicines in combination with standard drugs cured some patients in half the time of the current therapy of the injectable drug interferon and a pill called ribavirin. The older drugs require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate.

Prescribing instructions for Victrelis suggest that some patients with early responses to the drug can stop treatment after 28 weeks, while some others can stop at 36 weeks.

The most common side effects reported with Victrelis were fatigue, anemia, nausea, headache and taste distortion, the FDA said.

The drug label recommends monitoring for anemia.

Hepatitis C is spread mainly through sharing needles such as those used for illegal drugs and tattoos, or through blood transfusions before 1992 when screening began. Many people who are infected do not know they have the virus and show no symptoms.

The new medicines work by blocking a protein called protease that the virus needs to replicate. The generic name for the Merck drug is boceprevir. It must be taken three times a day with food.

(Reporting by Lisa Richwine and Bill Berkrot; Editing by Carol Bishopric)

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