Biodel Submits VIAject® for Treatment of Diabetes

Biodel, Inc. announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes.

VIAject® is Biodel’s proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It is Biodel’s most advanced product candidate and has been tested in more than 884 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel is seeking approval to market VIAject® in the United States as a 100 IU/cc, pH7 (neutral) injectable liquid, in 10 ml vials and 3 ml pen cartridges.

The NDA includes results from pharmacokinetic, pharmacodynamic and standardized meal studies, two pivotal 6-month Phase 3 clinical trials of VIAject® in patients with Type 1 and Type 2 diabetes, as well as interim results from the long-term, 18-month safety extension trials for patients who completed the pivotal Phase 3 clinical trials. The data from these studies consistently document the safety and efficacy of VIAject®.

Biodel’s chairman and chief executive officer, Dr. Sol Steiner, stated: “We believe our studies demonstrate that patients receiving VIAject® had faster reductions in blood glucose activity, reduced risks of hyperglycemia and hypoglycemia and less weight gain than patients who received recombinant human insulin, and that VIAject® may offer important clinical benefits to people with diabetes. I congratulate our team on submitting the NDA and reaching this important milestone in the development of our lead product candidate.”

About VIAject®

VIAject® is Biodel’s proprietary formulation of injectable human insulin for use at mealtime and in insulin pumps. It has been shown to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. VIAject®’s formulation allows insulin to disassociate, or separate, from the six molecule (hexameric) form to the single molecule (monomeric) form and inhibit re-association to the hexameric form, promoting more rapid delivery of insulin into the blood to produce its desired biological effects.

About the NDA

Since VIAject® is a modified form of recombinant human insulin, Biodel is submitting its new drug application for VIAject® under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act which governs the review of an NDA for a modified form of a previously approved product. This section of the act allows a pharmaceutical company to submit an NDA based in whole or in part on published literature or on the FDA’s finding of safety and efficacy of one or more previously approved drugs and may result in approval of a drug based on fewer clinical or nonclinical studies than would be required under a full NDA. Although no insulin product has been approved under this section of the act, Biodel believes its NDA for VIAject® qualifies for review under section 505(b)(2).

About Diabetes

Diabetes is a disease characterized by abnormally high levels of blood glucose and inadequate levels of insulin. Glucose is a simple sugar used by all the cells of the body to produce energy and support life. Humans need a minimum level of glucose in their blood at all times to stay alive. Insulin is a peptide hormone naturally secreted by the pancreas to regulate the body’s management of glucose. When a healthy individual begins a meal, the pancreas releases a natural spike of insulin called the first-phase insulin release, which is critical to the body’s overall control of glucose. All patients with Type 1 diabetes must treat themselves with mealtime insulin injections to compensate for the lack of natural pancreatic first-phase insulin release. As the disease progresses, patients with Type 2 diabetes also require mealtime insulin. However, none of the currently marketed mealtime insulin products adequately mimics the first-phase insulin release. As a result, patients using insulin typically have inadequate levels of insulin in their systems at the start of a meal and too much insulin in their systems between meals. This, in turn, results in the lack of adequate glucose control associated with diabetes. The long-term adverse effects of elevated glucose levels include blindness, loss of kidney function, nerve damage and loss of sensation and poor circulation in the periphery, which in some severe cases, may lead to amputations.

About Biodel Inc.

Biodel is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders such as diabetes. Biodel's product candidates are developed using technology which reformulates existing FDA-approved peptide drugs. For further information regarding Biodel, please visit the company's website at www.biodel.com.

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AstraZeneca, Bristol-Myers diabetes drug wins U.S. OK

AstraZeneca PLC and Bristol-Myers Squibb Co won U.S. approval on Friday to sell a new pill for adults with diabetes.

Onglyza enters a field clouded in recent years by concerns about heart-related risks. U.S. regulators have pressed manufacturers to more closely evaluate cardiovascular safety of proposed new medicines.

The Food and Drug Administration said Onglyza was not linked to increased heart problems in low-risk patients but the agency was requiring future study cardiovascular safety for higher-risk diabetics.

Though there are numerous diabetes therapies on the market, some cause weight gain or other complications and many patients do not reach optimal blood sugar levels, creating an opportunity for new treatments.

The companies hope Onglyza will carve out substantial sales by competing against Merck & Co's blockbuster drug, Januvia, which had $1.4 billion worldwide sales in 2008.

BMO Capital Markets analyst Robert Hazlett forecast Onglyza sales of $60 million in 2009, rising to $450 million in 2011 with peak sales approaching $1 billion over time.

Onglyza, a once-a-day pill known generically as saxagliptin, is AstraZeneca's first new drug since cholesterol fighter Crestor went on sale in 2003.

Both Onglyza and Januvia enhance the body's ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.

The drugs are cleared to treat Type 2 diabetes, which is linked with obesity, poor diet and lack of exercise. Nearly 24 million people in the United States, or nearly 8 percent of the population, have the condition, government statistics show.

FDA officials took a closer look at the cardiovascular safety of diabetes medicines after researchers linked GlaxoSmithKline PLC's pill Avandia to greater heart-related risks in 2007. A strong warning was added to the drug, although Glaxo says it is as safe as other approved diabetes medicines.

Onglyza's most common side effects include upper respiratory tract and urinary tract infections and headaches, the FDA said. Allergic-like reactions such as rashes and hives also were reported.
European regulators recommended approval of Onglyza in June, clearing the way for its launch there in the coming months.

Shares of Bristol-Myers gained 0.8 percent to close at $21.74 on the New York Stock Exchange. AstraZeneca shares gained 0.2 percent to close at $46.44, also on the NYSE.

Source : www.reuters.com

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New diabetes drug approved without trial

A new drug to combat diabetes, which is administered orally and not injected, was given a marketing approval by the Drugs Controller General of India (DCGI) without being put through the mandatory human clinical trials, highlighting a possible lapse in Indian laws dealing with the testing and approval of drugs.

The drug, Oral Recosulin, which was available in India from 27 January, was originally developed by Canada-based and Nasdaq-listed Generex Biotechnology Corp. and is marketed by Mumbai-based Shreya Life Sciences Pvt. Ltd. India is only one of the two countries where the drug is sold; the other is Ecuador, where it is sold as Oral-Lyn.

“Clinical trials for Oral Recosulin were not conducted in India. But we are currently conducting in India (a) phase IV trial,” said Ram Shelat, director (domestic business) at Shreya Life Sciences in an email.

A phase IV trial is conducted after a drug is given marketing nod to ensure that it doesn’t have any harmful side effects.

While insulin is not a new drug, Oral Recosulin is still classified as one by India’s Drugs and Cosmetics Act (DCA), since the delivery mechanism is new.

“Marketing approval given by the Drugs Controller General, India was unlawful because conventional insulin, instead of being injected, is to be given by spray via mouth. Any change in route of administration makes even an old, approved medicine, a ‘new drug’ as defined in the Drugs and Cosmetics Rules,” said Chandra M. Gulhati, editor of Monthly Index of Medical Specialities, a trade journal.

Repeated calls and emails to DCGI, over several days, remained unanswered.

The drug is being sold in India at Rs2,400 for a single pack. The price was approved by the National Pharmaceutical Pricing Authority in January based on DCGI’s approval, an official at the authority said on condition of anonymity.

Oral Recosulin is currently available in Delhi, Mumbai, Kolkata, Chennai, Hyderabad and Bangalore. It will soon be launched in Ahmedabad, Pune, Jaipur, Lucknow, Bhubaneswar and all other state capitals.

A marketing approval can only be granted once a new drug is proven to be effective and safe on the Indian population after so-called phase III clinical trials in the country.

When asked about the marketing approval being granted without clinical trials in India, Bill Abajian, executive vice-president (worldwide business) at Generex Biotech, said in a phone conversation that it was not possible for him to question the decision of India’s health ministry to approve the drug.

India’s DCA clearly states that an exception can be made only if it is in public interest and based on data available from other countries.

Mint was informed by Shreya Life Sciences that as of date, the only other country where the drug is marketed is Ecuador.

“This Latin American country, with a 14 million total population (less than that of Delhi) does not even have a drug controller,” said Gulhati.

Mint also reviewed the information on worldwide clinical trials put up on the website of Generex, which shows that at the time it received marketing approval for the drug in India, on 25 April, the administration of the drug had not begun in the phase III clinical trials being conducted on 750 patients with Type-1 diabetes across 36 centres located in the US, Canada, Russia, and Eastern Europe; these started in June.

The first result of this ongoing trial was announced on 10 March—42 days after the drug was launched in India.

Since the launch, Shreya Life Sciences has procured orders from nearly 60 doctors for over 100 patients in India, data on its website shows.

Even though Shreya Life Sciences received marketing approval from DCGI in April, Generex Biotech received permission and registration to import the drug for clinical trials in October 2007.

“This kind of (a) product requires a huge trial. I remember we gave them import licence and registration to conduct phase III trial,” said M. Venkateswarlu, the then DCGI.

However, this trial was not conducted in India.

Some doctors are hesitant to prescribe the product, especially after the failure of Pfizer’s inhaled insulin Exubera, launched in 2006 and later withdrawn in 2007, citing poor sales.

Generex, however, denied these apprehensions. “Unlike its failed counterpart, which was inhaled into the lungs, Oral-Lyn is absorbed through the tissue lining of the mouth and using a proprietary liquid formula, and ensures consistent dose-to-dose delivery without dangerous deposits in the lungs. Clinical trials, so far, have found no negative side effects at all, and, in fact, have found that oral insulin acts faster on blood glucose levels than even injected insulin,” the company said in an email.

“Most of this data are preliminary and anecdotal, and do not make a strong case for it. Its safety remains to be demonstrated, especially in view of (the) fiasco of inhaled insulin,” said Anoop Misra, director and head of department of diabetes and metabolic diseases, Fortis Hospitals, who reviewed the published papers.

He has not prescribed the drug to any patient. “Trials were done in Ecuador—again we don’t know much about it. This is an insufficient trial. The side effects are not clear due to inadequate data. We feel they were given a rather hasty permission and I feel very shaky in using it. You have to produce several papers that have been published in a reputed journal. That’s how Exubera was launched,” Misra added.

Source : www.livemint.com

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