Yesterday, shares of MannKind Corporation (MNKD) lost more than 30% following the disappointing news about the company’s proposed partnership deal for Afresa, its inhaled insulin product. MannKind stated, in a filing with the SEC, that the company will not be able to enter into a deal by year end, as was earlier expected. Although the company announced that it has made some progress in the partnership deal, we believe that any potential partner would wait for US Food and Drug Administration (FDA) approval to come before entering into any agreement. MannKind is seeking FDA approval of Afresa for the treatment of type I and type II diabetes. With a Prescription Drug User Fee Act (PDUFA) date of January 16, 2010 for Afresa, we believe a partnership deal is not likely before that. The approval of Afresa is significant not only from the company’s perspective but ...

On July 20, 2009, Amylin Pharmaceuticals Inc., (AMLN), Eli Lilly and Company (LLY) and Alkermes Inc. (ALKS) announced that their co-developed drug for type II diabetes, Exenatide once weekly was more effective in reducing average blood sugar over three months compared to Sanofi-Aventis' (SNY) Lantus (insulin glargine) on the basis of a 26-week open-label, clinical study in 467 patients with type II diabetes. Exenatide once weekly treatment also resulted in a mean weight loss of 5.8 pounds at 26 weeks, compared to a mean weight gain of 3.1 pounds for the Sanofi drug. This is again a desirable result as obesity is one of the primary causes of type II diabetes. Further, there were fewer cases of confirmed hypoglycemia (over-reduction in blood sugar) in patients treated with Exenatide once weekly compared to Lantus.  More than 23 million people in the U.S. are affected by diabetes, ...

For Immediate Release

Chicago, IL – July 24, 2009 – Four free stock picks are being made available today on Zacks.com. The industry’s leading independent research firm highlights one Zacks #1 Rank Strong Buy or a Zacks #2 Rank Buy stock for each of the four main styles of investing: Aggressive Growth, Growth & Income, Momentum, and Value.

The four highlighted picks are: Novo Nordisk (NVO), Casey’s General Stores, Inc. (CASY), International Business Machines (IBM) and Western Digital Corporation (WDC).      Today, Zacks is promoting its ''Buy'' stock recommendations. Four daily picks are offered free at http://at.zacks.com/?id=5607

Zacks #1 Rank Stocks have nearly tripled the S&P 500 since 1988, producing an average annual return of +26%. Performance has been notable even during volatile and down times. For example, during the last bear market, 2000-2002, the market tumbled -37.6% – but Zacks #1 Rank stocks gained +43.8%.

Here is

...

Positive Results on LAR from DURATION-3 Study Yesterday, Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS) announced positive results on exenatide once weekly long acting release (LAR) formulation from a phase III head-to-head study which compared LAR with Sanofi-Aventis’ (SNY) Lantus (insulin glargine). The 26 week study was conducted in type II diabetes patients (n=467) who were unable to achieve adequate glucose control on metformin therapy alone or in combination with a sulfonylurea. Results showed that LAR was more effective in reducing blood sugar levels compared to Lantus (6.8% vs. 7%). Moreover, patients on LAR therapy achieved a mean weight loss of 5.8 pounds compared with a mean weight gain of 3.1 pounds in patients treated with Lantus. This is important as data indicate that weight loss helps patients in their efforts to achieve and sustain glycemic ...

Headquartered in Hayward, California, Aradigm Corp. engages in developing inhalation drug products that enhance the quality of life of patients with severe pulmonary disease. Founded in 1991, the company has a team of scientists, engineers, and clinical experts who have been at the forefront of development of advanced inhalation delivery products.

Aradigm Corp.’s team pioneered the AERx® iDMS pulmonary delivery of insulin used in Phase 3 clinical trials conducted by their partner Novo Nordisk. Today, with experience and expertise in inhalation delivery, Aradigm is positioning their company to develop a portfolio of their own products to treat patients with severe respiratory diseases. The company’s current pipeline includes products undergoing development by Aradigm, or in partnerships with others, for the treatment of cystic fibrosis, inhalation anthrax, and pulmonary arterial hypertension. Aradigm Corp. is also investigating the use of their technology for tobacco smoking cessation therapy.

Aradigm’s AERx pulmonary drug delivery platform demonstrated

...

At last, the uncertainty regarding Sanofi-Aventis' (SNY) Lantus (generic name insulin glargine) seems to be over. Today, the company released a statement by a board of experts regarding the potential link of Lantus with increased cancer risk. They have come to the conclusion that all the four cases had significant methodological limitations and shortcomings, thus making the results inconclusive.

As a reminder, in the month of June, a study by the European Association for the Study of Diabetes observed that Lantus (generic name insulin glargine) increases the risk of cancer in diabetics taking the drug. The study, carried out on 127,000 patients in four European countries found that out of every 100 patients using Lantus for about 1 1/2 years, one additional person developed cancer.

But the FDA was not convinced with the study as patients were not studied long enough to substantiate the risk. Accordingly, it planned to review the

...

NDA acceptance not enough for Alkermes On July 7, 2009, Alkermes, Inc. (ALKS), Eli Lilly (LLY) and Amylin Pharmaceuticals, Inc. (ALNY) announced the acceptance of the New Drug Application (NDA) for once-a-week diabetes drug Exenatide by the U.S. Food and Drug Administration (FDA). Exenatide once weekly is being co-developed by the three companies for type II diabetes. The application was filed by Alkermes in May 2009. Exenatide is an active ingredient of Byetta injection. It is presently available in the U.S. and in many countries across the globe as a treatment for type II diabetes patients who fail to achieve good glycemic control with commonly available oral therapies. Byetta is injected twice a day as against the once a week administration of the proposed drug. If approved, Exenatide once weekly would be the first and only once-a-week therapy for the treatment of ...

* FBR Capital downgraded Alcoa (NYSE:AA) to "underperform" from "market perform," citing valuation and oversupply concerns

* According to an unidentified report of a clinical study out of Europe, insulin users of long-acting drugs showed increased cancer risks. Manufactures of such drugs include Sanofi Aventis (NYSE:SNY) and Novo Nordisk (NYSE:NVO), while Amylin (NASDAQ:AMLN) manufactures a non-insulin-based treatment

* According to news reports, Novartis (NYSE:NVS) is in talks to acquire parts of Elan (NYSE:ELN), including its multiple sclerosis drug Tysabri and its pipeline of Alzheimer's drugs

Zacks Investment Research

Will inhaled insulin be a reality, this time for MannKind?MannKind Pharma (MNKD) witnessed its share price rise by a whopping 141% since the beginning of the year with positive outlook for its inhalable insulin Afresa.MNKD has already invested about $1 billion into developing Afresa, which if approved will be much more convenient to use than the frequent injections diabetic patients have to take. In May, the FDA accepted the NDA [new drug application] for Afresa, though its approval is not expected before early 2010.The inhaled insulin market has witnessed major changes during last year with Pfizer (PFE, marketed product Exubera), Lilly (LLY) and Novo Nordisk (NVO) withdrawing their late-stage candidates. While Pfizer blamed the pullout on poor sales of the drug (only $12 ...

Emisphere [EMIS: 0.00, N/A (N/A)] is an emerging bio-pharma company specializing in the development of a drug delivery technology platform for the oral administration of therapeutic compounds which are either poorly absorbed or must be given through alternative routes such as injections.

On 6/1/09, EMIS announced that Novartis [NVS: 41.95, +1.66 (+4.12%)] and Nordic Bioscience have completed recruitment for the planned second multi-center Phase 3 study exploring the safety and efficacy of an oral formulation of salmon calcitonin using Emisphere’s proprietary Eligen Technology to treat patients with osteoarthritis of the knee. This study, which is intended to be used to support a FDA regulatory approval filing in the U.S., includes more than 900 patients between the ages of 51-80 with a medical history and symptoms of knee osteoarthritis. The study is being conducted in Europe and the U.S., as well as other countries, and is

...