J.D. Bear asks, "KV Pharmaceuticals (KV-A) recently received approval for Makena, a.k.a. progesterone, for prevention of preterm birth. Progesterone was first approved by the FDA in 1957. It has been used for birth control, promotion of pregnancy, hormone replacement therapy, menstrual disorders, and prevention of preterm birth. It is readily available from compounding pharmacies at low cost."Now that KV has got an approval they want $30,000 for a course of treatment that previously cost a couple hundred dollars. They have reportedly sent out cease and desist letters to the compounding pharmacies threatening some kind of FDA enforcement action. My question: What is there to enforce? As I understand the law, KV has exclusive rights to label and advertise their product as treatment for preventing preterm birth. Aside from that labeling right, is there any reason to believe the FDA will stop compounding pharmacies from supplying generic progesterone, as prescribed by physicians, for such reasons they see fit?" You're correct. FDA doesn't have the legal right to regulate compounding pharmacies, according to the latest court decision in a long-running legal battle between the two sides. That means compounding pharmacies, if they so choose, can still make and sell the progesterone product 17P for doctors who want to prescribe it for the prevention of pre-term birth. Alere ( ALR), one of the countries largest providers of 17P and related services, recently sent a letter to doctors informing them that the company will continue to offer the drug. "Alere is committed to continue offering our current 17P Administration Service without interruption, which we pioneered in 2003 after the use of this compound was endorsed for specific patient indications by national medical societies such as the American College of Obstetricians and Gynecologists (ACOG)," the Alere letter to doctors states. KV is the exclusive manufacturer of FDA-approved 17P, which it intends to sell under the Makena brand name, but compounding pharmacies and companies like Alere can still manufacture and sell less-expensive 17P if they so choose. KV has every legal right to launch Makena at $1,500 per dose even when the same drug, manufactured by compounding pharmacies and used for years, is priced at $10 to $20 per dose. The strategy hasn't exactly made KV many friends -- politicians, doctors groups and insurance companies have all criticized the company publicly for its super-sized pricing policy. At the same time, however, some large insurance companies have said they will cover the extra cost of Makena, and KV has pledged to help low-income patients pay for the drug. KV is apparently willing to swallow the bad press if that means walking away with outsized Makena revenue.
David B. revisits an old friend: "What's up Adam? Let's see we're now three months past your prediction of Cell Therapeutics (CTIC - Get Report) being bankrupt. Oh look at that, 'Cell Therapeutics Strikes Cancer Deal with Chroma.' What happened, Adam? Remember all those Jim Bianco-bashing comments? Remember it's not your fault. You can't help it. It's all about your past!" I don't recall a column from three months ago in which I predicted bankruptcy for Cell Therapeutics. I have tried to pound home the message repeatedly that Cell Therapeutics is chronically short of cash and investors face massive dilution as the company continues to sell large amounts of stock in order to fund operations. That fact remains undeniably true. Cell Therapeutics had more than 800 million shares outstanding at the end of 2010, a figure that's moving briskly towards a whopping 1 billion shares outstanding with the January financings and many more to come. Cell Therapeutics still doesn't have enough cash on hand to maintain basic company operations, fund the new clinical trial of pixantrone, pay off debt due later this year and now pay 75% of development costs for the new experimental drug licensed from Chroma Therapeutics. Cell Therapeutics paid $5 million upfront to license tosedostat from Chroma. That's small change for a cancer drug entering phase III studies. Cell Therapeutics CEO Bianco may be a wheeler-dealer but he didn't steal away a highly coveted asset. Tosedostat is more likely a bargain-bin remainder. A more typical cancer drug licensing deal look like the $50 million Human Genome Science ( HGSI) paid upfront Wednesday for rights to a phase I/II drug from FivePrime Therapeutics. The lead indication for tosedostat is in elderly patients with acute myeloid leukemia (AML). A single-arm phase I/II study of 51 patients demonstrated an overall response rate 27%, including a complete response rate of 14%. The median duration of response was a bit longer than three months. Toxicity concerns reported in the study included reduced platelet counts and increases in liver enzymes. The results from this study were published in the Journal of Clinical Oncology in October 2010.
Last Thursday, Spectrum Pharmaceuticals ( SPPI - Get Report) reported fourth-quarter earnings of 8 cents a share on revenue of $34 million. Top- and bottom-line results were better than expected and helped boost Spectrum's stock price from $6.90 to a bit more than $8 a share. After Spectrum's earning report, I tweeted, "I'm still underwhelmed by Zevalin sales performance. $8M in Q4, the sequential growth should be better." This prompted a response from @nexparadigm: "So why the enthusiasm? First non pro-SPPI comment I've seen." Let me explain my tweet further. Spectrum's fourth-quarter results were strong, no doubt, but the numbers were boosted by a one-time surge in sales of its cancer drug Fusilev to $23 million. For comparison's sake, Fusilev sales for the preceding three months of 2010 totaled $9 million.
Depomed ( DEPO) and Abbott Labs ( ABT) did what the NFL and its players could not: Reach a mediated settlement regarding marketing rights to Gralise, a new formulation of the generic drug gabapentin approved in January to treat shingles-related pain. In an agreement announced Wednesday night, Abbott returned Gralise commercial rights to Depomed and will pay the small drug maker $40 million. Depomed, in turn, plans a commercial launch of Gralise in the U.S. in the fourth quarter, targeting specialty pain doctors. The company will also try to find a new marketing partner to sell Gralise to primary care physicians.
Another follow-up on Apricus Biosciences ( APRI) @DrewDog12380 tweeted to make sure I saw an Apricus announcement this week regarding the formation of a clinical advisory board to plan the clinical development of Femprox as a treatment for female sexual arousal disorder, also known as female sexual dysfunction. Femprox is a topical formulation of alprostadil, the same active ingredient contained in Apricus' erectile dysfunction cream Vitaros. Alprostadil works by relaxing blood vessels and enhancing blood flow. When applied to the penis, men can achieve erections. The idea behind Femprox is similar -- increase blood flow to the vagina, thereby increasing vaginal lubrication and sexual arousal. Apricus owns full rights to Femprox and future plans include meetings with FDA to reach agreement on the design of a phase III clinical program, the company says. The use of topical alprostadil to treat female sexual arousal disorder (FASD) has been tried unsuccessfully before. Vivus ( VVUS) halted the development of a topical alprostadil known as Alista in 2007 after the failure of a randomized, controlled phase IIb study of 320 women. In that study, treatment with Alista over six months produced a doubling over baseline of satisfying sexual events, however the difference between Alista and placebo was not statistically significant.