Replies to post #93589 on Biotech Values

[DewDiligence]

Good addition to the table—I like the way you’re thinking globally :- ) (DYAX was in an earlier version of this table, but it was removed because the company plans to commercialize DX-88 on its own in the US.)

[DewDiligence]

OREX revised some Contrave efficacy metrics downward in an 8-K filing today:

http://sec.gov/Archives/edgar/data/1382911/000119312510082049/d8k.htm

Not issuing a PR for such consequential information is an odd decision, IMO.

These are the slides from OREX’s investor presentation today:
http://sec.gov/Archives/edgar/data/1382911/000119312510082049/dex991.htm

[DewDiligence]

MNKD Jumps on Afrezza Safety Update

http://blogs.barrons.com/stockstowatchtoday/2010/04/23/mannkind-jumps-as-afrezza-shows-positive-safety-data

›Friday, April 23, 2010 ET
By Tiernan Ray

Shares of biotech MannKind (MNKD) are up 54 cents, or 8.6%, at $6.80, after the company this afternoon issued a press release saying that its inhaled insulin treatment currently in development, “Afrezza,” caused no significant change in the structure of patients’ lungs and were similar to the effect upon pulmonary functioning of other treatments for diabetes.

The results demonstrate the safety of the device, MannKind’s chief scientific officer Peter Richardson said. Today’s announcement follows a March 16 “complete response letter” from the Food & Drug Administration that requested a “routine safety update” for Afrezza prior to approving the drug for sale.

The FDA letter had pushed down Afrezza shares dramatically at the time, and some analysts speculated whether the drug would have to address concerns of it could prompt afflictions, including lung cancer.

Today’s note should put to rest some if not all of those concerns. Rodman & Renshaw analyst Simos Simeonidis, who has a “Buy” rating on the stock, and an $18 price target,†gave me his view on the results in a phone call this afternoon.

“There’s been a lot of doubt on Wall Street this drug can get approved. The other inhalable insulin, Exubera, had a lot of lung function issues and some thought Afrezza might have the same issues come up.”

“The data is important because they’re showing lung function is not an issue but they’re also showing efficacy,” said Simeonidis. “The data show in Type 1 diabetics, Afrezza had the same reduction in HBA1C (hemoglobin) as traditional insulin treatments, with an almost identical reduction.”

That meets the requirement to show Afrezza is “not inferior” to existing treatments, whether or not it’s superior, concludes Simeonidis.

Furthermore, people with Afrezza actually lost weight, rather than gaining weight, as some do with traditional treatments, a positive.

The next step is to hear that the company is meeting with the FDA to discuss the complete response letter. After that, it may take up to six months for the FDA to offer a response.‹

[DewDiligence]

Late-Stage Products Looking for a Home

Criteria for inclusion:
a) Program has completed phase-2b or later and is non-partnered; AND
b) Company lacks the financial resources to commercialize the product on its own.


Edits: Removed DDSS’ Oleptro, which was offloaded to a JV with an Italian company.

 
 Company  Product     Phase   Indication (notes)  
 =======  =======     =====   ==================  
 ARNA     Lorcaserin  NDA     Obesity  
 BPAX     Libigel     3       Female Sexual Desire Disorder  
 DYAX     Kalbitor    US app  acute hereditary angioedema (seeking x-US partner)  
 HNAB     Marqibo     2B      ALL (ENZN failed accelerated approval in NHL)  
 JAV      Dyloject    NDA     Post-op pain (approved in UK)  
 JAV      Ketamine    3       Acute pain  
 OREX     Contrave    NDA     Obesity  
 OXGN     Zybrestat   3       Anaplastic thyroid cancer  
 MNKD     Afrezza     BLA     Diabetes (CRL rec’d 3/15/10)  
 Pharming Rhucin      BLA     HAE (rejected and resubmitted in EU)  
 SOMX     Silenor     apprvd  Insomnia (low dose of generic doxepin)  
 SVNT     Krystexxa   BLA     Gout (response to CRL submitted 3/30/10)  
 VVUS     Qnexa       NDA     Obesity 

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