When Great Obesity Study Results May Not Be Enough (OREX)
Orexigen Therapeutics, Inc. (NASDAQ: OREX) is moving in after-hours trading. The company has just announced that its first of four Phase III trials of its lead investigational product Contrave met its co-primary and key secondary endpoints. Be advised that there are questions about how this really fits in with the “targets” and the stock is indicated lower after the results.
This showed a significant reduction in body weight, improvements in markers of cardiovascular risk and reductions in selected food craving measures. If you can believe it, the result was a loss of about 20 to 25 pounds. This was with an exercise regimen and did include counselling, but generally speaking many who need to lose that much do better with ongoing reviews.
Here is the full release from the company.
Jon C. Ogg
January 8, 2009
Wal-Mart Lands In Middle of Diabetic Product Recall (COV, WMT)
Covidien, Ltd. NYSE: COV) and the FDA have notified patients and healthcare professionals of a product recall which has been sold to diabetics. Wal-Mart Stores Inc. (NYSE: WMT) gets to find itself at yet another controversy, yet it isn’t really Wal-Mart’s fault on the surface.
This recall is covering the ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles used by insulin-dependent diabetes. These syringes were sold only by Wal-Mart or Sam’s Club pharmacies under the ReliOn name.
The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes.
If you need to read more, here is the official notice.
Jon C. Ogg
November 6, 2008
Biodel Meets Two-Face, The Joker, & The Riddler…..
If you just read headlines, you might have thought that Biodel Inc. (Nasdaq: BIOD) was going to have a good day. But it’s the exact opposite. Biodel has released study data from its pivotal Phase III trials for VIAject which met the primary endpoint of non-inferiority and results which demonstrated statistically significant reductions in hypoglycemic events and weight gain in Type 1 and 2 diabetes.
But the problems may be around the weight gain as the Type 2 diabetes patients showed a 0.7 pound weight gain over 26 weeks and Type 1 patients lost 0.7 pounds over that period. There were also results seen India that did not coincide with results in the US and Germany, which had to be excluded from results.
In both clinical trials, swelling, itching and redness were reported in less than 5% of patients receiving VIAject or RHI. VIAject was associated with injection site pain, the prevalence of which decreased with time. A combined total of 24 VIAject patients dropped out of the two clinical trials due to injection site pain (cry-babies).
The company is pleased with the decreases seen in hypoglycemic events and over those receiving insulin alone.
Shares are down almost 70% at $5.33 as of 9:53 AM EST and we have seen more than 2.5 million shares trade hands. The 52-week trading range was $9.60 to $25.69. The company may be pleased, but Wall Street isn’t. Not at all.
With a $126 million market cap, the stock trades at about 1.25 times its last stated net tangible assets as of June 30, 2008.
Jon C. Ogg
September 8, 2008
New Potential Diabetes Treatments On The Horizon?
Telik, Inc. (Nasdaq: TELK) has announced that the publication of research in “Bioorganic & Medicinal Chemistry Letters” describes a novel class of small molecule compounds that could potentially lead to a new treatment for diabetes. The company noted that these unique compounds are the result of an extensive medicinal chemistry effort at Telik to optimize the original lead structure identified through the application of Telik’s TRAP technology.
Telik noted that the compounds developed activate the insulin receptor and may have the potential to be an orally administered treatment for diabetes. It also notes that such small molecules have been actively sought and could represent a completely different approach to the treatment of Type 1 and Type 2 diabetes.
Telik’s publication “5-Substituted isophthalamides as insulin receptor sensitizers” describes a series of compounds capable of activating the insulin receptor and were also shown to increase glucose transport into adipocytes.
Telik shares are indicated slightly higher, although no trades have been seen as of 9:10 AM EST. This closed at $0.95 yesterday and its 52-week trading range is $0.93 to $4.96. Its market cap based on the close was only $50.5 million.
Jon Ogg
July 8, 2008
MS & Diabetes Hopeful Bayhill No Longer IPO Candidate
Bayhill Therapeutics Inc. was a company we had been expecting to come public for a while. This was going to be a play on autoimmune diseases like multiple sclerosis, but the company has now has withdrawn registration for what it had listed as an $86.25 million IPO.
You can probably guess the reason: unfavorable market conditions.
This was one of the ones we had followed ahead of the IPO because the company has raised what appears to be north of $60 million in venture capital funding rounds. Traditionally, companies in biotech that raise more than $25 million in venture capital tend to come onto many investor radars from VC’s to investors to institutions.
U.S. Venture Partners, Morgenthaler Ventures, De Novo Ventures, CMEA Ventures, Lilly Ventures,and others have stakes from various funding stages.
The company’s MS treatment study is actually beyond initial Phase II stage, and its diabetes study is still in Phase I studies. Investors are likely going to have to hold out longer for a new IPO that would have served these major opportunities.
Jon C. Ogg
June 30, 2008
Emisphere Scores on Novo Nordisk Pact (EMIS, NVO)
Emisphere Technologies, Inc. (NASDAQ: EMIS) is seeing a major surge in pre-market trading this morning after the company was designated a pact with Novo Nordisk A/S (NYSE: NVO). The companies enetered into an exclusive development and license agreement to develop and commercialize oral formulations of Novo Nordisk’s GLP-1 receptor agonists for the potential of treating Type 2 diabetes.
This pact will use Emisphere’s eligen technology and will generate payments to Emisphere by Novo Nordisk. This will include at least $87 million in product development and sales milestone payments to Emisphere. Of this amount, some $10 million will be the minimum first year payment, as well as royalties on sales.
This signed agreement will also give Novo Nordisk the option to develop oral formulations of Novo Nordisk compounds other than GLP-1 receptor agonists using Emisphere’s proprietary carrier technology.
Further financial details of the agreement were not made public. We might be much more questionable since this all depends on commercialization of the new sales. But Novo Nordisk is the key leader in diabetes treatment and has the best reputation for the entire sector.
To put this in perspective Emishpsphere’s market cap was a mere $60 million before this morning’s news. Emisphere is also a pre-revenue stage company. Shares are very thinly traded this morning with a huge illiquid spread. But the last trade was at $2.80, up some 41%. We’ve only seen 4,8000 shares change hands as of 9:02 AM EST and the average volume is only about 66,000 shares per day. Its 52-week trading range is $1.28 to $5.17.
Jon Ogg
June 23, 2008
Insulet Downgrade Scuttles Insulin System Maker (PODD)
Insulet Corporation (NASDAQ: PODD) is seeing shares hit pretty hard today on strong volume. The news is that Canaccord Adams issued an stock ratings Downgrade this morning and it slashed its prior Buy rating down to an unenthusiastic Hold rating. Of all the analysts that cover the stock, this is the first rating to go cautious on the stock. The medical device company of an insulin infusion system for people with insulin-dependent diabetes is down over 9% today at $16.14. This one has been public for a just over a year.
Jon Ogg
June 20, 2008
Vivus' Qnexa: Better for Diabetes, or Better for Weight Loss? (VVUS)
Vivus Inc. (NASDAQ: VVUS) issued its awaited results on its mid-stage trial of its experimental drug Qnexa, showing that it lowered blood sugar levels and led to weight loss in patients with Type II diabetes.
The results are from its 28-week trial involving 206 subjects, and Vivus said that patients on Qnexa achieved a 1.2% reduction in the key blood sugar measurement hemoglobin A1c compared to a drop of -0.6% for those who received only the placebo.
Qnexa is also being developed for obesity, and the disclosed amount was a loss of approximately 8% of the patients’ starting body weigh. The placebo group reported a loss of 1.2% of their starting body weight.
Vivus also reported that Qnexa trial patients also had significant improvement in cardiovascular risk factors including blood pressure, triglyceride levels and waist circumference.
Qnexa is potentially not going to go entirely unchallenged or at least might not escape without at least some controversy, particularly considering the history of the company and the history of the compounds. It is a combination of phentermine from “fen-phen” and an epilepsy drug Topamax (generic as topiramate).
Shares have been mixed today despite this being reported as and being perceived as positive news. Shares are up less than 1% at $7.05 after 90 minutes of being open, although shares have traded in a $6.81 to $7.22 trading range today alone.
Jon Ogg
June 10, 2008
Amylin Results Better Than Stock Performance? (AMLN, LLY, ALKS, NVO)
Last night we saw the long-awaited results from Amylin Pharmaceuticals Inc. (NASDAQ: AMLN), Eli Lilly & Co. (NYSE: LLY) and Alkermes Inc. (NASDAQ: ALKS) announce their results from their one-year open-label clinical study for a once/week Byetta treatment in type II diabetes in patients who are taking metformin but still don’t have their blood sugar under control.
The results showed that the durable efficacy sustained a similar improvement in their glucose control compared to those receiving treatment for 30 weeks. The results also showed that patients who switched from a BYETTA injection after 30 weeks to exenatide once weekly also experienced additional improvements in A1C and fasting plasma glucose.
Byetta has been on the market since 2005 and exenatide is not yet approved.
If you have watched Amylin over the last few days, it has been a tough patch for the stock as the diabetes competitor Novo-Nordisk AS (NYSE: NVO) results were far better than Wall Street was expecting. On Friday, shares were north of $32.00 and they closed down at $26.84 yesterday.
While there has been relatively thin volume with under 30,000 shares with 1 hour and 10 minutes to the open, shares are up marginally in pre-market trading but are also already off the highs. Unfortunately with an over an hour and a low-grade reaction to what seems like good news it is hard to see any major reaction so far.
Jon Ogg
June 10, 2008
Analysts Chase Diabetes and Insulin Stocks (AMLN, NVO)
Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) is seeing some major trading volume this morning to the downside. The culprit today after prior weakness is a downgrade over at Jefferies & Co. where the firm cut its stock ratings from a “Buy” down to a much less attractive “Hold” rating.
This is the second such day consecutively that Amylin is being pounded. Friday its shares fell from almost $33.00 down to $29.93 after a study showed that Novo-Nordisk AS (NYSE: NVO) outperformed it in diabetes trial results.
Amylin has seen over 4.2 million shares trade by 11:30 AM EST and shares are down over 9% to $27.24. Its 52-week trading range is $23.75 to $53.25.
Elsewhere, Novo Nordisk AS (NYSE: NVO) shares are essentially flat today on an analyst upgrade. HSBC Securities raised a prior unattractive rating of “UNDERWEIGHT” to a “Neutral” rating. As that isn’t exactly a ringing endorsement, there has been little activity there and share have risen from $64.00 in the last 5-day trading period.
Jon Ogg
June 9, 2008
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