This morning’s eight-week top-line interim results for Lipocine’s LPCN 1144 in non-alcoholic steatohepatitis contain plenty of “red flags” and do not hold up to scrutiny, STAT’s Adam Feuerstein writes in a new report. Shares of Lipocine are up 31%, or 49c, to $2.08 in midday trading.
Thursday, January 17, 2019
Ladenburg reiterates Buy rating, $5 price target on Lipocine after NASH data
Ladenburg analyst Matthew Kaplan reiterates his Buy rating and $5 price target on shares of Lipocine after the company announced interim results from the ongoing 16-week liver fat imaging study with LPCN 1144. He said he is encouraged by these preliminary, 8-week results, which show a rapid reduction in liver fat levels from baseline based on MRI assessment, and looks forward to the full study results later this year. Kaplan also noted that Lipocine is working to resolve the four issues detailed in the CRL received in May 2018 and he expects results from the “rate-limiting” AMB BP study in late Q1.
Ligand business model improving despite 60% share selloff, says H.C. Wainwright
Shares of Ligand Pharmaceuticals (LGND) are down 60% from September 28 to yesterday while the company’s business model continues to improve, H.C. Wainwright analyst Joseph Pantginis tells investors in a research note titled “Yelling Fire in a Quality Filled Theater; Bear Case Has Been Winning But Remains Misguided.” The analyst writes, “We think it may be a waste of energy to refute all the misperceptions and false comments we have read in other firms’ freely accessible research and therefore highlight what we believe to be the main points which continue to solidify our bullish thesis on Ligand.” Growing revenue led by royalties, approximately $1B of cash on the balance sheet, and a broad portfolio of assets support Ligand’s “consistently improving” business model, Pantginis contends. With more than 178 current “shots on goal” in the form of fully funded partnered programs, the analyst sees the company’s risk as “significantly diversified from a valuation standpoint.” Further, Ligand’s partnerships provide long-term revenue growth potential even if the roughly “one in 10 drugs make it” concept is met, adds the analyst. He reiterates a Buy rating on Ligand Pharmaceuticals with a $281 price target. The stock in afternoon trading is down 30c to $109.75.
Novel Oral Antibiotic Treatment Seysara™ (sarecycline) Now Available
Almirall LLC announces the launch of Seysara™ (sarecycline), a novel tetracycline-derived oral antibiotic developed specifically for the treatment of acne. Seysara™ was approved in October 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe non-nodular inflammatory acne vulgaris in patients 9 years of age and older, and is now commercially available.
“Seysara™ was the first new chemical entity for the treatment of acne to be approved by the FDA in a decade, and the acquisition of the product in September 2018represented a significant investment by our company in the future of medical dermatology,” said Peter Guenter, CEO of Almirall. “This launch further demonstrates our commitment to our healthcare partners and patients in the U.S.”
Seysara™ is one of five former Allergan products acquired by Almirall, comprising a balanced portfolio of mature and growth brands including Aczone® (dapsone), Tazorac® (tazarotene), Azelex® (azelaic acid) and Cordran® Tape (flurandrenolide).
In the two identical Phase 3 clinical trials (SC1401 and SC1402), a significant number of patients receiving once-daily Seysara™ experienced improvement of their acne severity at 12 weeks versus placebo based on the Investigator’s Global Assessment (IGA) (21.9% vs 10.1% SC1401; 22.6% vs 15.3% SC1402). Seysara™ also led to a reduction in the number of inflammatory acne lesions at 12 weeks (51.8% vs 35.1% SC1401; 49.9% vs 35.4% SC1402), with significant results seen as early as week 3 (29.6% vs 22.4% SC1401; 28% vs 18.6% S1402).2,3,4
“Unlike most other pivotal acne studies, the Seysara™ trials analysed the impact of the study drug on chest and back acne where it was also shown to be effective,” stated Angela Moore, MD a coordinating investigator and Clinical Assistant Professor in Dermatology at the University of Texas Southwestern (UTSW), “In addition, this will be one of very few acne treatments that are FDA approved for patients 9 years of age.”
In clinical trials, treatment with Seysara™ was found to be generally safe and well-tolerated, with low rates of treatment-emergent adverse events (TEAEs) reported in the Seysara™ safety study which followed subjects up to 52 weeks. Patients receiving Seysara™ reported no cases of vertigo or tinnitus and fewer cases of dizziness than seen in the placebo group. Less than one percent of patients experienced photosensitivity or sunburn, and rates of GI issues were relatively low. The most common adverse reaction (incidence ≥ 1%) was nausea.2,3,4
“Acne is affecting an increasing number of patients, and we are always looking for ways to improve our treatment management. Seysara™ showed a statistically significant reduction in inflammatory acne lesion counts with an early onset, and a favorable tolerability profile. I believe that Seysara™ can play a major role in our future treatment decisions,” said Linda Stein Gold, MD, coordinating investigator and Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan.
Acne vulgaris is a common skin condition involving blockage and/or inflammation of hair follicles and their glands, which can present as non-inflammatory lesions, inflammatory lesions, or a mixture of both, affecting the face, back and chest. According to the Global Burden of Disease study, acne vulgaris affects 85 percent of young adults aged 12–25 years around the world. In the United States, 80 percent of people will experience acne vulgaris at some time during their lives, one in five of whom have severe acne.5
“Seysara™ is an exciting new product in the acne space, where unmet needs still exist for patients ranging from pre-teens through adulthood,” said Ron Menezes, President and General Manager of Almirall U.S.
He went on to state, “We have a passionate, committed team, and we are looking forward to partnering with the dermatology community to deliver innovative therapies like Seysara™ to those who may benefit from them, building on our shared goal of improving skin health outcomes for patients.”
To access the Seysara™ patient copay card visit Almirall Copay. For more information on the Almirall product portfolio please visit Almirall US.
Seysara™ (sarecycline) is a once-daily, oral tetracycline-derived antibiotic with anti-inflammatory properties for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Seysara™ has proven to be a safe and effective treatment in two identical 12-week multicenter, randomized, double-blind, placebo-controlled studies (Study 1 [NCT02320149] and Study 2 [NCT02322866]). Efficacy was assessed in a total of 2,002 subjects 9 years of age and older.
Seysara™ (sarecycline) is a once-daily, oral tetracycline-derived antibiotic with anti-inflammatory properties for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Seysara™ has proven to be a safe and effective treatment in two identical 12-week multicenter, randomized, double-blind, placebo-controlled studies (Study 1 [NCT02320149] and Study 2 [NCT02322866]). Efficacy was assessed in a total of 2,002 subjects 9 years of age and older.
Alzheon Leaves IPO on the Table for the Second Time
The third time may be the charm for Framingham, Mass.-based Alzheon when it comes to an initial public offering – because the company has balked the first two times it attempted to go public on the stock exchange.
In April 2018, the company initially planned an $80 million IPO, but then withdrew the offer. Then, in August, the company announced intentions for a more modest $40 million IPO, but has once again, opted to withdraw that option. The company notified the U.S. Securities and Exchange Commission on Jan. 16 of its decision to withdraw the IPO plan.
The latest filing with the SEC did not provide any reasoning behind the decision to withdraw its IPO. It noted though that Alzheon is “no longer pursuing an initial public offering of its common stock,” according to the filing signed by Chief Executive Officer Martin Tolar. Alzheon did say in its latest filing that it could “undertake a subsequent private offering” for its stock.
Alzheon is a company working in the risky area of Alzheimer’s disease, a treatment space where many companies have seen their products crash and burn in countless studies. Alzheon’s lead product is ALZ-801, an orally-administered inhibitor of beta-amyloid misfolding. Beta-amyloid has been one of the leading targets for Alzheimer’s researchers as a primary cause of memory loss and cognition issues that are associated with the dreaded disease. Many of the drugs that have failed, such as Eli Lilly’s solanezumab were focused on amyloid-beta. However, with those failures, many researchers are questioning that avenue, but Alzheon continues that route, particularly in light of a recent discovery.
In August, Alzheon announced the discovery of an endogenous substance in the human brain that inhibits the formation of neurotoxic beta-amyloid (Aβ) oligomers, which are key drivers of Alzheimer’s disease pathogenesis. The substance was identified as 3-sulfopropanoic acid (3-SPA), the primary metabolite of tramiprosate and of its prodrug ALZ-801 in humans, the company said. ‘
Alzheon CEO Tolar said the results from the discovery suggest a potential protective role of endogenous 3-SPA in normal human brains, guarding against the formation of beta-amyloid oligomers that cause neurodegenerative disorders such as Alzheimer’s.
“In addition, our results suggest a potential contribution of 3-SPA to the clinical efficacy of ALZ-801 and connect it more closely to the protective effects against neurotoxic amyloid oligomers. While targeting soluble amyloid aggregates is the only therapeutic approach to date that has shown a disease-modifying effect in Alzheimer’s patients, no drugs have been approved yet that can slow or stop the disease. This new discovery and mechanistic data strongly support our therapeutic approach and strengthen Alzheon’s commitment to confirm the efficacy of ALZ-801 in APOE4 carriers, a genetically-defined subset of Alzheimer’s patients,” Tolar said at the time.
Alzheimer’s and other forms of dementia are a growing healthcare concern. In the United States, Alzheimer’s disease is the sixth-leading cause of death across all ages and the fifth-leading cause of death in people over 65 years of age. By 2050 the number of global patients is expected to hit 131.5 million.
Lipocine’s LPCN 1144 shows positive action in liver fat study
Thinly traded nano cap Lipocine (NASDAQ:LPCN) is up 125% premarket on robust volume following its announcement of encouraging data from an open-label single-arm study evaluating NASH candidate LPCN 1144 in 36 hypogonadal males with at least 10% baseline liver fat.
Interim data on seven patients with average baseline liver fat of 21% showed an absolute reduction from baseline of 7.6% and a 38% relative reduction. The responder rate was 86% (n=6/7) (defined as at least a 4.1% absolute reduction in liver fat) and 71% (n=5/7) with a 29% absolute reduction criterion.
No new safety signals were observed.
16-week data should be available later this quarter.
LPCN 1144 is an oral prodrug of what the company says is “bioidentical” testosterone.
Cardinal Health initiated at UBS
Cardinal Health initiated with a Neutral at UBS. UBS analyst Kevin Caliendo started Cardinal Health with a Neutral rating and $51 price target.
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