Amylin & Friends Brace for Diabetes Review (AMLN, LLY, ALKS)
Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) has a big event on deck this week. This Friday, March 12, is its Prescription Drug User Fee Act (PDUFA) action date for an FDA panel to issue a recommendation on Byetta as the the first once a week treatment for Type II diabetes. The date had been moved due to recent weather closures in February in and around Washington D.C.
Analysts are mixed on the stock with BMO cutting its rating last week, but there were two positive calls from Credit Suisse and Jesup & Lamont.
Options are elevated today, but not overly active. The open interest of stock options is also large enough that the $20 synthetic options straddle would imply that shares have to rise above $24.70 or drop below $15.30 to be profitable.
Byetta is already sold with Eli Lilly & Co. (NYSE: LLY), and Alkermes, Inc. (NASDAQ: ALKS) provides the technology that makes Byetta last longer in the delivery mechanism for a once per week use. Open interest in the Alkermes options is elevated but not astronomical.
There is a risk here for a potential delay on top of what has already been seen. Some feel the FDA will delay this recommendation with a request for more side effect data.
Amylin is currently believed to be the winner of ultimate once-weekly approval, even if a delay comes this week. But that notion also depends upon whom you ask. The most recent short interest data shows about 16.25 million shares (almost 12% of the float) are listed as being in the short interest. The stock is at $20.10 and the 52-week trading range is $7.89 to $20.46. That 52-week high was also hit today.
JON C. OGG
Disappointment & Delay in Diabetes War (MNKD, LLY, NVO, PFE)
MannKind Corp. (NASDAQ: MNKD) is getting to learn more and more about disappointment, and the rumors and speculation that MannKind would not get its Afresa reviewed on time by a January 16 cut-off date turned out to be true. Afresa is designed to deliver a fast acting inhalable insulin that is supposed to be more effective than the injected products and it would put the company in competition for insulin with Eli Lilly & Co (NYSE: LLY) and Novo Nordisk (NYSE: NVO) for their insulin delivery. Pfizer Inc. (NYSE: PFE) discontinued its Exubera as an inhalable insulin, which is part of the reason for such a negative bias around MannKind’s Afresa.
MannKind’s Alfred Mann noted that the FDA has not yet completed its inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind; and he also noted that (to its knowledge) all other FDA inspections of third-party suppliers and clinical trial sites are complete and that there are no pending answers to any FDA questions or other deliverables due on MannKind’s part. And by the way, the FDA has accepted the name to now be AFREZZA as the trade name versus AFRESA before. MannKind has not yet been informed about the expected timing for the agency’s final determination on the NDA, which will be provided in an Action Letter.
We had hinted at this possible delay and speculation against MannKind during the week when we noted that the diabetes and insulin wars were about to heat up.
There was a big wave of selling at the end of the day. There have been rumors and reports that the FDA may not meet its deadline, so we won’t blatantly say that this was leaked out first. Still, the drop-off was at least something to be noticed, and you can see below the very active options trading and in the open interest for the JAN-2010 and FEB-2010 CALLS and PUTS.
JAN-2010 CALLS & PUTS
CALL$ Volume OpInt
7.50 5,370 24,648
10.00 1,971 23,608
PUT$ Volume OpInt
5.00 1,195 8,329
7.50 741 8,677
FEB-2010 CALLS & PUTS:
CALL$ Volume OpInt
5.00 2,961 8,845
7.50 1,960 18,475
10.00 8,307 38,668
12.50 771 17,132
15.00 1,035 11,626
PUT$ Volume OpInt
5.00 4,659 15,259
7.50 4,192 14,017
10.00 2,163 12,100
JON C. OGG
Diabetes & Insulin War About To Heat Up (MNKD, LLY, NVO, PFE, BMY, AZN, GERN)
MannKind Corp. (NASDAQ: MNKD) has not gone without its critics over the company’s inhaled insulin. The company has an upcoming review that will be a make or break event for the company. The company is about to face a potential do or die test next week as the FDA is set to decide the fate of the company’s inhaled insulin. MannKind’s Afresa is designed to deliver a fast acting insulin that is supposed to be more effective than the injected products. This would put the company in competition for insulin with Eli Lilly & Co (NYSE: LLY) and Novo Nordisk (NYSE: NVO) for their insulin delivery.
One of the biggest hurdles MannKind faces is that inhaled insulin products have been tried and tested by others, and they have failed or have fallen far short of the expectations set ahead of time. Pfizer Inc. (NYSE: PFE) discontinued its Exubera as an inhalable insulin.
- Lexicon Pharmacueticals (NASDAQ: LXRX) had a favorable Phase I reaction late last year in type 2 diabetes mellitus.
- These companies are all also fighting for their part of that next $170 billion market opportunity.
- Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN) already received FDA approval for Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
- Geron Corporation (NASDAQ: GERN) is still a ways off for the stem cell angle here compared to its other stem cell endeavors, although you never know when stem cell companies will make periodic announcements.
The FDA is set to make a ruling on Afresa’s approval by January 16, which means that the JAN-2010 CALL options may or may not expire before such ruling is made. The FDA can always delay, and some reports hint at a later date now.
Read more
Developments in the War on Lung Cancer (OSIP, ONTY, LLY)
We have seen some developments over the last week on the companies that aim to fight lung cancer. OSI Pharmaceuticals Inc. (NASDAQ: OSIP) has an FDA review event coming up this week for Tarceva. We also wanted to review what occurred this week in Oncothyreon Inc. (NASDAQ: ONTY) and Eli Lilly and Company (NYSE: LLY), as well as noting some crazy activity in a penny stock.
OSI Pharmaceuticals Inc. (NASDAQ: OSIP) may have been forgotten about during the holiday rush. The company already had its analyst meeting on December 3, but we have this one marked with a December 16 FDA advisory committee meeting for Tarceva as a first-line maintenance therapy treatment against non-small cell lung cancer. The company said that Tarceva is the only oral, non-chemotherapy agent shown to provide a statistically significant improvement in both progression-free survival and overall survival in the NSCLC maintenance setting. At $34.75, its 52-week trading range is $27.01 to $43.00. If we use the 4 closest strike prices on put and calls combined, there is only just over 5,000 contracts in the open interest, so it seems that binary event traders in biotech are not giving this much of a grade one way or the other.
Oncothyreon Inc. (NASDAQ: ONTY) rose sharply on Thursday, yet gave back some gains on Friday. The company last week said Merck KGaA has launched a Phase III trial of its Stimuvax vaccine in Asian patients with advanced non-small cell lung cancer and it is developing the cancer vaccine under a license with Oncothyreon. The companies are already trying the drug in several other studies for other indications. Stimuvax is designed to stimulate the body’s immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in NSCLC as well as in other common cancer types such as breast cancer, multiple myeloma, and colorectal, prostate and ovarian cancers.
Eli Lilly and Company (NYSE: LLY) gave analysts its pipeline update and financial guidance for 2010 this last week. In its presentation, one of the many drugs under study was Necitumumab (IMC- 11F8). The company noted that it has 2wo Phase III studies of necitumumab which have been initiated in non-small cell lung cancer. The first of these commenced dosing in November 2009, while the second study is expected to commence before the end of 2009. A pivotal trial in colorectal cancer will follow. Unfortunately for Lilly, if you did not count a whole $0.05 gain in the stock on December 9 this would have been a sever day losing streak.
I apologize for covering a pink sheet stock ahead of time. A company called HARD TO TREAT DISEASES (Pink Sheets: HTDS) had to comment on recent trading activity: HTDS management would like the public to know that the only changes in the company’s fundamentals have been positive. As our shareholders will remember, we recently closed important new sales, added new marketing and technical advisors and had world-class research advances. While it is only a fraction of a penny, it is hard to not notice 85 million shares… “We continue with our daily business activities, the research into MS, Lung cancer with our www.mindupbioresearch.com project to name a few.”… We are offering you a link here to the company’s announcement, because it is obvious something is afoot here after noting many issues.
Jon C. Ogg
December 13, 2009
VIVUS Tapping ED Hurdles (VVUS, PFE, LLY)
VIVUS Inc. (NASDAQ: VVUS) may soon have a new erectile dysfunction drug on the market if the test results lead to an FDA approval. Shares are trading higher this morning after it announced positive results in a phase 3 pivotal study evaluating the safety and efficacy of avanafil for the treatment of erectile dysfunction.
If everything is as solid as it sounds, it looks like Pfizer (NYSE: PFE) via Viagra and Eli Lilly & Co. (NYSE: LLY) via Cialis may have a new competitor.
The 646 patient study met the safety and efficacy enpoints of avanafil, with what may be some lower side effects than traditional ED drugs. The endpoints were also met across the three doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile and improvements in the International Index of Erectile Function score.
Nearly 80% of sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse. Full efficacy was reported by patients in 30 minutes or less, which is better than current ED drugs. Full efficacy was maintained for all doses across multiple time points beyond six hours.
The company also noted that all FDA-defined primary endpoints were met across all three doses of avanafil, and it was well tolerated as demonstrated by a high retention rate (85%). More importantly, there were no drug-related serious adverse events in the study and patients had low reports of common PDE5i side effects.
VIVUS shares are up 13% at $9.72 in pre-market trading and the 52-week trading range is $2.72 to $12.88.
JON C. OGG
BioHealth Job Cuts Keep Coming (AZN, PFE, BSX, BMY, LLY, JNJ)
It used to be that pharmaceutical jobs and medical device maker jobs were among the best and most immune of all sectors in the economy. They paid well, there was job security, the benefits were solid, stock option and retirement plans were always growing, and on. That is still the case in many positions inside those companies. But mergers, competition, efficiency, redundancy, and a new spending environment are changing this for many jobs in these once-safe sector.
Mergers have led to many “efficiencies” to be realized, and allowed “redundancies” (i.e. low-yield jobs and departments) to be eliminated. And now there is an ongoing threat to the sector from Washington. While the target has gone away from all of healthcare to health insurance, we are still seeing the announcement from major companies of more job cuts. We have compiled a few of the latest found announcements, ad this is just a part of the whole pie.
AstraZeneca PLC (NYSE: AZN) is reportedly offering buyouts “to thousands of its near-5,000 workers” from its U.S. sales force.
Pfizer Inc. (NYSE: PFE) has outlined more job cuts from its Wyeth combination as part of a projected 15% cut to the combined Pfizer-Wyeth team. What this number will ultimately come to is still unknown, and Pfizer’s head count had already fallen by over 6,000 to 75,400 at the end of last quarter.
Boston Scientific (NYSE: BSX) had job cuts a couple years ago, and it appears that the job cuts may not be over. Recent health reform legislation from the Senate Finance Committee was noted by its CEO as being an event which could potentially trigger another 1,000 to 2,000 job cuts.
Bristol-Myers Squibb Co. (NYSE: BMY) has been in an ongoing 10,000 layoff mode since last year, but in the last week came word that about 25% of its Abilify antipsychotic drug sales force after an evaluation from its co-marketing pact with Otsuka Corp. These were recent cuts and are still unquantified.
Eli Lilly and Co. (NYSE: LLY) announced last month that it is targeting $1 billion in savings… with the elimination of up to 5,500 jobs total by some time in 2011.
This summer came the announcement from Johnson & Johnson (NYSE: JNJ) about its plan to cut up a range of 3,615 to to 4,800 jobs. That is a small amount considering the number of deals it has made and considering it has 120,000 employees.
JON C. OGG
OCTOBER 20, 2009
BioHealth Earnings Floodgates Opening (BSX, BIIB, GILD, ISRG, PFE, DGX, SYK, AMGN, ELN, LLY, GENZ, STJ, BMY, MRK, SGP, ZMH)
Next week is going to be the mother of all earnings reports for the BioHealth community. We have included the key device companies as well in this calendar with the routine top drug and biotech companies. As a reminder, these estimates may change between now and when some of the players report earnings. In the screens for earnings we have the estimates included listed as the Thomson Reuters consensus figures.
MONDAY OCTOBER 19
- Boston Scientific Corporation (NYSE: BSX) $0.14 EPS on $2.04 billion in revenues
TUESDAY OCTOBER 20
- Biogen Idec Inc. (NASDAQ: BIIB) $1.04 EPS on $1.11 billion in revenues
- Gilead Sciences Inc. (NASDAQ: GILD) $0.67 EPS on $1.76 billion in revenues
- Intuitive Surgical, Inc. (NASDAQ: ISRG) $1.46 EPS and $256.44 million in revenues
- Pfizer Inc. (NYSE: PFE) $0.48 EPS and $11.4 billion in revenues
- Quest Diagnostics Inc. (NYSE: DGX) $0.96 EPS and $1.89 billion in revenues
- Stryker Corp. (NYSE: SYK) $0.69 EPS and $$1.62 billion in revenues
WEDNESDAY, OCTOBER 21
- Amgen Inc. (NASDAQ: AMGN) $1.27 EPS and $3.79 billion in revenues
- Elan Corporation, plc (NYSE: ELN) -$0.13 EPS on $285.18 million in revenues
- Eli Lilly & Co. (NYSE: LLY) $1.01 EPS and $5.4 billion in revenues
- Genzyme Corporation (NASDAQ: GENZ) $0.44 EPS and $1.11 billion in revenues
- St. Jude Medical, Inc. (NYSE: STJ) $0.58 EPS and $1.16 billion in revenues
THURSDAY, OCTOBER 22
- Bristol-Myers Squibb (NYSE: BMY) $0.51 EPS and $5.5 billion in revenues
- Merck & Co., Inc. (NYSE: MRK) $0.83 EPS and $6 billion in revenues
- Schering-Plough Corporation (NYSE: SGP) $0.39 EPS and $4.45 billion in revenues
- Zimmer Holdings Inc. (NYSE: ZMH) $0.86 EPS and $953.6 million in revenues
JON C. OGG
OCTOBER 16, 2009
Diabetes Drug War Heats Up (NVO, AMLN, LLY, MNKD, PFE, SPEX, VVUS, GNBT, BMY, AZN, ARNA, GERN, STEM, OREX, HDIX, PODD)
Over the last couple of weeks, there has been quite a bit of new data in the drug war in the fight against diabetes. New studies have been updated, earnings projections have been made, FDA dates have been telegraphed and more. While these are still far short of ultimate cures, the war against diabetes may have many new or improved treatments out sooner rather than later. We originally discussed one or two of the key upcoming treatments pending for the eight major diseases and conditions as “the next $170 billion opportunity” and this is a much deeper dig into that broad initiation. We have included many of the recent developments in the potential treatments for obesity as well, considering that Type II diabetes and obesity are frequently conditions tied directly to each other.
According to the Journal of Health Affairs, the figure on obesity for Americans is a whopping $147 billion per year in total medical costs. This comes to 10% of all healthcare spending. The figure from the U.S. Centers for Disease Control was some $116 billion spent domestically on treating diabetes in 2007. As this is a lengthy bit, we have not included some of the other treatments that have been in use or that were recently flagged because of reports of higher chances of cancer rates associated by the long-term use of these.
FDA & IMMEDIATE ACTION
There is a new diabetes hopeful that is supposed to be coming sooner rather than later. Novo Nordisk (NYSE: NVO) reported a 21% gain in earnings in the last week and said that it expects the FDA to make a decision on its next-generation diabetes drug Victoza (liraglutide) in a matter of weeks. The company’s CFO and CEO both indicated that the Danish company does expects a positive response from the FDA and we heard a August to September expectation. Novo Nordisk has already launched Victoza in England, Germany and Denmark last month and expects to release it in other European Union countries throughout 2009 and into 2010. The benefit is that this one doesn’t risk pushing blood glucose levels to counts which are dangerously low and it also helps users lose weight. Novo Nordisk said it has priced Victoza competitively with Byetta from Amylin Pharmaceutical, Inc. (NASDAQ: AMLN) and Eli Lilly (NYSE: LLY). After the earnings and after shares were still close to 52-week highs, we saw analyst downgrades on Friday for Novo Nordisk by both UBS and by J.P. Morgan.
The drug still expected the next big new release with Blockbuster potential is an inhalable insulin from MannKind Corp. (NASDAQ: MNKD). Afresa is to be its name. Despite past woes of inhalable insulin, MannKind shares were hitting 52-week highs in June and its shares are still up 20% from three months ago. A late-stage study showed that Afresa’s performance was similar to injectable insulin. The company recently sold a 7.4 million shares secondary offering to raise cash for this launch, and its CEO took 1 million shares of the offering. The thought was that MannKind would secure a partner for marketing and development, but the recent stock offering gives it more internal options ahead of what is believed to be a Spring-2010 FDA approval action. Pfizer Inc (NYSE: PFE) has been thought of as a partner as it moved Exubera inhaled-insulin patients to MannKind’s experimental product. The two companies had been partners until Pfizer pulled Exubera from the market in 2007.
There is also a huge opportunity for the once per week dosing. We are not yet convinced that this can be a universal next generation treatment, however this might be fine for many of the lower grade cases if you can refer to any diabetes cases as lower grade. Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN), Eli Lilly (NYSE: LLY) and Alkermes Inc. (NASDAQ: ALKS) have had a recent New Drug Application accepted by the FDA for review. Exenatide is an investigational sustained release medication for type 2 diabetes that would be injected once per week and is the active ingredient in BYETTA. We are not alone in this thought, but Amylin is a company which many have thought would be acquired for years now when considering the link of diabetes and obesity.
VIVUS, Inc. (NASDAQ: VVUS) has a substantial shot here with Qnexa, its Type 2 diabetes treatment through weight loss assistance. The stock recently came off on worries of its risk factor language that may have to be disclosed, but it showed a 9.4% weight loss or over 20 pounds observed in patients. The DM-230 study was a 56-week study assessing the impact of Qnexa on glycemic management in 130 obese patients. The 10-site study was comprised of 90 females and 40 males with an average age of 50 who had Type 2 diabetes, and a majority of the patients had been diagnosed with diabetes for more the five years and were taking two or more oral diabetes medications. In the phase II and phase III clinical trials, Qnexa demonstrated glycemic control, significant weight loss, and an improvement in cardiovascular risk factors. VIVUS is also presenting data at a brokerage firm conference this coming Thursday. The company’s market cap is still just under $500 million and its most recent balance sheet had north of $144 million in cash and equivalents with very little long term debt.
Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN) have recently received FDA approval for Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. This Onglyza is a once-daily dipeptidyl peptidase-4 (DPP4) inhibitor that can be used in combination with commonly prescribed anti-diabetic medications or on a standalone basis as a monotherapy to significantly reduce glycosylated hemoglobin levels.
MORE OBESITY CANDIDATES COMING
Several biotechnology companies are working on the next wave of obesity candidates, as noted above in VIVUS’s Qnexa. Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) has Lorcaserin, Orexigen Therapeutics, Inc. (NASDAQ: OREX) has Contrave, and Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) has pramlintide. Orexigen’s Contrave has completed phase III trials and our time line for when the company will file for approval is in early 2010. The company is presenting data this Thursday at the Canaccord Adams Global Growth Conference. VIVUS’s Qnexa is currently in two phase III programs with a new drug application expected around the middle of 2010. Amylin’s pramlintide and metreleptin are currently in phase IIb.
We have the expectation that Arena will have a first-mover advantage with an NDA planned before the end of 2009. Certainly, any delays or advances could change the status of the front-runner category leadership. Arena’s near-term catalyst is the release of the phase III BLOSSOM data out in September 2009, which will be used as part of a supplemental NDA in late 2009 or into 2010. This still leaves a year or more for final FDA action from now. Arena shares surged in late-July after reporting that its obesity results met the three endpoints.
STEM CELLS
Stem Cell therapy offers a huge promise, but so far that looks to be years out and the promise is actually more of a hope for the time being. Geron Corporation (NASDAQ: GERN) is in the research stage of using stem cells in evaluation of Type 1 diabetes. The exact level of this study is not as far as along as some of its cancer and spinal studies, but this is one of the few stem cell companies that have dedicated part of their mission to diabetes. StemCells Inc. (NASDAQ: STEM) also has a Pancreatic Program concentrating its efforts on Type-I diabetes. Its goals are to identify, isolate, and culture pancreatic stem and progenitor cells, and to test their therapeutic potential.
While we at BioHealthInvestor would love to hold hope and promise for stem cells, we would not be hoping for stem cell treatments any time in the near future. While some positive notions have been noted in the stem cell sector, the National Institute of Health noted, “Over the past several years, doctors have attempted to cure diabetes by injecting patients with pancreatic islet cells—the cells of the pancreas that secrete insulin and other hormones. However, the requirement for steroid immunosuppressant therapy to prevent rejection of the cells increases the metabolic demand on insulin-producing cells and eventually they may exhaust their capacity to produce insulin. The deleterious effect of steroids is greater for islet cell transplants than for whole-organ transplants. As a result, less than 8 percent of islet cell transplants performed before last year had been successful.”
Have Acadia Pharma shares rallied to far, too fast? (ACAD, LLY, AZN, BVF)
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) have roughly doubled over the past two trading days on expectations that the Phase III clinical data for its Parkinson’s related psychosis candidate pimavanserin will be released soon, and the trial will meet its primary endpoint.
Institutional investors are piling on heavily in the options market on nearly 20 times average volume, as the stock’s chart now shows breakout potential to $8.
Top-line results for the first of two Phase III trials is expected by the end of the third quarter, which has the market positioning for potentially positive news in coming days.
Last April, pimavanserin met the endpoint of the study as it did not worsen Parkinson’s symptoms. The candidate was well tolerated by test subjects. It also showed promise as a co-therapy for schizophrenia in a Phase II study back in March 2007.
Nearly $16.7 billion will be spent in the U.S. this year on medications to treat mental illnesses including bipolar disorder schizophrenia, according to Thomson Pharma. The top drug in the antipsychotic category is the bipolar disorder drug Seroquel, made by AstraZeneca plc (NYSE: AZN), with expected sales of $5.4 billion, accounting for about a third of all antipsychotic drug sales. The No. 2 drug in the category is Eli Lilly & Co.’s (NYSE: LLY) Zyprexa, for treating bipolar disorder and schizophrenia. Expected sales this year are $4.6 billion.
Has the stock rallied too much? Perhaps. The stock has added nearly $90 million in market value over the past two sessions. The speculative rise in value comes on anticipation that the candidate could find a market among a potential market of only 600,000 patients in the U.S. But pimavanserin may only have a small portion of that market, especially at the beginning.
The market now appears to be pricing in expectations that pimavanserin will find a specialized market in Parkinson’s patients, as well as a larger market in treating Alzheiemer’s disease psychosis. If approval were granted for both conditions, the drug could then reach a potential market of 2.5 million patients or more.
That however, is not likely to happen for several more years, if it happens at all. – Mike Tarsala
Why Byetta may be the efficacy leader among many diabetes candidates (LLY, ALKS, SNY, NVO, GSK)
Partners Eli Lilly & Co. (NYSE: LLY) And Alkermes Inc. (Nasdaq: ALKS) announced data Monday that further supports its weekly Byetta candidate, although the FDA still may have questions about the entire class of long-acting diabetes treatments.
The data in the anticipated Duration 3 trial of once-weekly Byetta was solid. The candidate demonstrated better efficacy in a head-to-head comparison to Sanofi Aventis’ (NYSE: SNY) Lantus once-daily injection, the class leader. In a trial involving 467 Type 2 diabetes patients, once-weekly Byetta showed a 1.5 percent reduction in A1c levels vs. the baseline, compared to a 1.3 percent reduction for Lantus.
An added benefit of taking the drug may be weight loss. The mean weight loss for once-weekly Byetta patients was 5.8 pounds during the 26-week trial. Mean weight loss was 3.1 pounds for study subjects taking Lantus.
There were no new safety concerns raised. Common side effects were respiratory infection and nausea.
It’s hard to compare all the drugs in the class against one another, but it appears based on the efficacy data that once-weekly Byetta may put it at the top of a class that includes Lantus, Novo Nordisk’s (NYSE: NVO) Victoza, and GlaxoSmithKline’s (NYSE: GSK) Avandia.
The big lingering question is the FDA’s view of all the diabetes drug candidates called GLP-1 analogs. The agency is reviewing heart-related safety data of candidates among many of the drugs in the class.
It also may be looking at possible cancer ties. The journal Diabetologia, associated with the European Association for the Study of Diabetes in late June published four studies that made a possible link between Sanofi’s Lantus and cancer. The studies fell short of making a direct link, but they raised plenty of questions. At the time, analysts became concerned that more questions could be asked about many drugs, if not the entire class of long-acting diabetes drugs.
The FDA’s view of Novo Norisk’s candidate could be important to the entire group. In April, its heart-related safety was seen as mostly favorable, based an 8-to-5 FDA panel vote. The decision was split, however, on if it should be put on the market. That company’s earnings report in early August might specify the FDA’s upcoming timeline. The drug received EU approval earlier this month.
The Novo Nordisk FDA timing may provide clues as to whether the FDA want to see more studies for many, if not all drugs in the class, which may extend the approval processes. — Mike Tarsala
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