Mar. 4, 2015, 8:23 AM
- Based on the findings of an independent advisory panel, the FDA issues a formal announcement that restricts testosterone drug makers from promoting their products for age-related low testosterone, an ever-increasing target of prescriptions. The number of men being prescribed testosterone jumped over 75% between 2009 and 2013.
- The agency asks (not really a request) manufacturers to change their labeling to clarify that their products are only approved for men with specific medical conditions and that taking the drugs could increase their risk of heart attacks and strokes.
- The agency also requests that manufacturers of approved products, including skin patches, solutions, intramuscular injections and topical gels, conduct studies to determine if their treatments increase cardiovascular risk.
- Last year, the FDA mandated that testosterone product makers update their labeling to include a warning about the risk of blood clots.
- Related tickers: (NYSE:ABBV) (NASDAQ:ENDP) (NYSE:LLY) (NASDAQ:ATRS) (NASDAQ:RPRX) (NASDAQ:LPCN) (NYSE:TEVA) (NASDAQ:AUXL)
Dec. 15, 2014, 12:36 PM
- Added to the Nasdaq Biotechnology Index, effective Dec. 22: AAVL, AERI, AKBA, ALDR, ALIM, AMPH, ANIP, ASPX, CARA, CGEN, CLDN, CNCE, ENTA, FLML, FMI, FOLD, FPRX, GWPH, HPTX, ICPT, INO, INSM, KITE, KPTI, MGNX, OPHT, PCYC, PETX, POZN, PTX, QLTI, RARE, RCPT, RDUS, RLYP, RTRX, RVNC, SAGE, TBPH, TTPH, VSAR, XLRN, ZFGN, ZSPH.
- Deleted: AMRN, AUXL, CRIS, EXPR, ICEL, ONTX, RIGL, ZGNX.
Dec. 12, 2014, 7:19 AM
Nov. 19, 2014, 11:55 AM
- The U.S. Federal Trade Commission terminates the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for Endo International's (ENDP -0.8%) intended acquisition of Auxilium Pharmaceuticals (AUXL +0.6%).
- As previously announced, Endo will acquire all of the outstanding shares of Auxilium for $33.25 in a cash-and-stock deal valued at $2.6B. The transaction should close in Q1 2015.
- Previously: Auxilium agrees to sale to Endo for $2.6B
Oct. 30, 2014, 6:38 AM
- Auxilium Pharmaceuticals (NASDAQ:AUXL): Q3 EPS of $0.27 beats by $0.17.
- Revenue of $109.6M (+1.4% Y/Y) beats by $8.58M.
Oct. 14, 2014, 11:43 AM
- The FDA's PDUFA date for reviewing Auxilium Pharmaceuticals' (AUXL +1.9%) sBLA requesting approval of Xiaflex (collagenase clostridium histolyticum) for the treatment of two Dupuytren's contracture cords concurrently is October 20.
- Xiaflex is presently cleared for the treatment of adult Dupuytren's contracture patients with a palpable cord and for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Oct. 13, 2014, 8:03 AM
- Lipocine's (NASDAQ:LPCN) oral testosterone replacement therapy candidate, LPCN1111, demonstrates positive top-line results in a 12-patient Phase 2a feasibility study in hypogonadal males.
- Study participants with serum total testosterone <300 ng/dL received a single dose of LPCN1111 (330 mg, 550 mg, 770 mg) followed by once-daily administration of 550 mg for 28 days (10 subjects) or once-daily administration of 770 mg for 28 days (eight subjects).
- The proportion of the 550 mg and 770 mg cohorts with 24-hour serum testosterone concentration within the normal range was 67% and 88%, respectively. The typical target for regulatory approval is 75%.
- A Phase 2b is expected to begin in Q1 2015.
- TRT-related tickers: (NASDAQ:RPRX) (NYSE:LLY) (NYSE:ABBV) (NASDAQ:AUXL) (NYSE:TEVA)
Oct. 9, 2014, 9:14 AM
Oct. 9, 2014, 6:48 AM
- The stock and cash deal works out to a price of $33.25 for each share of Auxilium (NASDAQ:AUXL) vs. last night's close of $29.76, and represents a 55% premium to AUXL's closing price on Sept. 16, the day Endo International (NASDAQ:ENDP) made public its purchase proposal.
- Endo's earlier rejected bid had been for $2.2B.
- Auxilium owners may elect to receive consideration of all stock (0.488 ENDP shares for each share of AUXL), or all cash, or an equal mix of stock and cash.
- Previously: Auxilium says Endo offer a bit light but is willing to talk
Sep. 24, 2014, 10:52 AM
- Lipocine's (LPCN +40.8%) oral testosterone replacement therapy candidate, LPCN 1021, achieves its primary efficacy endpoint in a Phase 3 clinical trial.
- The FDA guidelines for primary efficacy success stipulate a minimum of 75% of trial subjects on active treatment achieve a serum testosterone concentration within the normal range of 300-1140 ng/dL and the lower bound of the 95% CI (confidence interval) must be greater than 65%.
- In the Phase 3 study, 88% of LPCN 1021-treated patients achieved testosterone levels in the normal range with a lower bound CI of 82%.
- LPCN 1021's safety profile was acceptable as well. Three percent of the subjects reported a serious adverse event, though none were drug-related. All drug-related adverse events were mild or moderate. The safety extension phase of the trial is ongoing.
- One aspect of the value proposition of oral TRT therapy is the elimination of the risk of inadvertent testosterone transfer associated with transdermal gels (before the gel dries).
- Related tickers: (LLY +0.6%)(ABBV +1.1%)(RPRX +8.1%)(AUXL -0.2%)(TEVA +0.4%)
Sep. 22, 2014, 12:18 PM
- Auxilium Pharmaceuticals' (AUXL -0.3%) BOD says that Endo International's (ENDP -1.7%) $2.2B bid "significantly undervalues" the company. Despite implementing a poison pill takeover defense, it says that it maintains the right to engage in discussions with Endo. ENDP says that it is willing to work with AUXL on a deal.
- A marriage with Endo would probably scupper Auxilium's agreement to merge with Canadian eye drug manufacturer QLT, Inc.
Sep. 22, 2014, 10:47 AM
- Plandai Biotechnology (OTCQB:PLPL -3%) plans to develop and test an all-natural product for erectile dysfunction (ED). The compound, called icariin, is an extract from the plant Epimedium, also called the horny goat weed. Icariin is a phosphodiesterase type 5 (PDE5) inhibitor similar to sildenafil, the active ingredient in Viagra.
- The company has begun cultivating and cloning epimedium and expects to begin testing on a potential ED product in mid-2015. Icariin is less potent than sildenafil, but Plandai believes its extraction process will enhance epimedium's absorption and retention in the bloodstream to a sufficient degree that it will be a viable all-natural ED treatment alternative.
- Related tickers: (PFE -0.7%) (LLY -0.5%) (GSK +0.4%) (OTCPK:BAYRY +0.9%)(AUXL -0.7%)
Sep. 18, 2014, 1:31 PM
- In a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee today, members vote 18-3 against approval for privately-held Clarus Therapeutics' oral testosterone Rextoro.
- The committees voted yesterday 20-1 in favor of revising who should be prescribe testosterone replacement therapies (TRT) and the need to conduct further studies to assess the cardiovascular risks. The revised population of patients appropriate for TRT will be much smaller as a result.
- Related tickers: (LLY +0.9%) (ABBV -0.5%) (RPRX -25.4%) (LPCN -25.3%) (AUXL -0.5%) (TEVA +0.3%)
Sep. 18, 2014, 7:40 AM
- In a joint meeting between the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members vote 20-1 in favor of drug developers' need to further assess the cardiovascular risks of testosterone products. Sixteen voted that it should be studied only in certain situations.
- Members also voted 20-1 in favor of a revision of who should be prescribed the drugs. The panel says there is little evidence that testosterone replacement therapies (TRT) are effective for treating low levels of hormone caused by aging.
- Prescriptions for TRT products almost doubled from 2010 to 2013. About 20% of TRT patients do not have laboratory evidence that they need the therapy.
- Eli Lilly (NYSE:LLY) says that current evidence does not support a causal link between TRT and cardiovascular events. Based on the committee's statements, though, it will work with the FDA on how to communicate the cardiovascular risk to patients.
- The committees meet today to discuss Clarus Therapeutics' NDA for an oral testosterone.
- Related tickers: (NYSE:ABBV) (NASDAQ:AUXL) (NYSE:TEVA)
Sep. 18, 2014, 7:15 AM
- The FDA approves a label expansion for Vivus' (NASDAQ:VVUS) erectile dysfunction (ED) drug Stendra (avanafil) that reduces the time it can be taken before sexual activity from 30 minutes down to 15 minutes. It is the only ED drug approved for this indication.
- Auxilium Pharmaceuticals (NASDAQ:AUXL) has exclusive marketing rights to Stendra in the U.S. and Canada.
- The 15-minute approval triggers a $15M milestone payment from Auxilium to Vivus.
Sep. 17, 2014, 12:45 PM
Auxilium Pharmaceuticals, Inc., is a specialty biopharmaceutical company, which develops and markets products to urologists, endocrinologists, orthopedists and select primary care physicians and plastic surgeons who focus on the hand, and rheumatologists.
Industry: Drug Related Products
Country: United States