Search This Blog

Friday, June 1, 2018

Sanofi tweaks pricing policies, discloses 8.4% net price decline in 2017


Pharma companies have faced years of criticism for their pricing, responding with pledges to limit price increases and “transparency reports” detailing how list price hikes and substantial rebates play into overall costs. Sanofi has implemented both strategies, and recently disclosed new figures showing that its net prices sank 8.4% last year.
That decline came after an average aggregate price hike of 1.6% across its portfolio, according to updated figures (PDF) by the drugmaker. Sanofi last year pledged to limit its price hikes to the National Health Expenditure growth rate established every February by the Centers for Medicare and Medicaid Services.
Now, it’s slightly updating its policy: The company is adopting new standards by April 1 of every year and will provide rationale when it raises drug prices above the NHE metric.
For one example, Sanofi last year raised the price of recombinant protein-based flu vaccine Flublok Quadrivalent by 12.5%, or $5 a dose to $45 per dose for the 2017-2018 season. Sanofi said the higher price reflects “substantial benefit” seen from the vaccine’s efficacy in people 50 and older compared to traditional flu vaccines.
Flublok was the only price hike out of 29 at Sanofi that came in above the NHE growth rate of 5.4% last year, the drugmaker said. This year, CMS is predicting NHE growth of 5.3%.
Amid an intense pricing debate in past years, several pharma companies such as Allergan and AbbVie pledged to limit price hikes to single digits. Others have released “transparency reports” showing the cumulative effect of list price hikes and rebates. Johnson & Johnson, for instance, reported that it paid out $15 billion in rebates and discounts last year, resulting in a 4.6% net price decline across its portfolio.
Merck also realized a net price loss last year, though its decline was smaller at 1.9%. Eli Lilly’s net price increase was 6% for the year.
In addition to providing portfolio-level pricing figures and limiting price hikes, Sanofi says it’ll give clear rationale for drug pricing at launch. In 2017, it launched immunology meds Dupixent at $37,000 per year and Kevzara at $39,000 per year. On Dupixent, Sanofi said the price reflects benefit seen for atopic dermatitis patients and savings realized elsewhere in the healthcare system and for employers.
Kevzara’s price reflects clinical value for patients, the drugmaker said. The figure is 30% lower than the two most widely used TNF-alpha inhibitors in the industry, according to Sanofi.
In 2016, Sanofi raised list prices across its portfolio by 4%, but its net prices fell 2.1% due to rebates and discounts.
After a multiyear pricing firestorm that kicked off with controversies such as Turing’s Daraprim and Mylan’s EpiPen, President Donald Trump’s administration in May rolled out a plan to lower drug costs. It includes proposals to increase negotiations and competition, provide incentives for lower list prices and help patients with lower out-of-pocket costs.
It remains to be seen where the administration’s plan will take the drug industry in the long run, but a consultant told FiercePharma it will likely be “business as usual” for pharma in the short term.
In response to pricing criticism in 2016, Allergan CEO Brent Saunders said drugmakers should police themselves or risk regulatory overhaul. He wrote about industry’s “social contract” and started the pricing pledge trend. More recently, Eli Lilly CEO David Ricks said this year is the “time for action” on pricing because there are key personnel in the Trump administration who understand the “fragile balance between reward for innovation and access.”

Cancer vaccine seeker Neon Therapeutics looks for $115M in IPO


Neon Therapeutics filed to raise $115 million in its Nasdaq IPO, capital that will support a pair of ongoing clinical trials, as well as additional trials, of its lead asset, NEO-PV-01, a personalized neoantigen cancer vaccine made from up to 20 antigens harvested from patients’ own tumor cells.
The cash will also fund research and preclinical programs, including NEO-PTC-01, a neoantigen T-cell therapy being developed for solid tumors, and NEO-SV-01, a neoantigen vaccine for breast cancer, according to an SEC filing. The company plans to push both into phase 1.
Cambridge, Massachusetts-based Neon bases its personalized immuno-oncology treatments on neoantigens, or antigens that are foreign to the body but found in cancer cells and so can be leveraged to drive the immune system to attack tumors. It previously banked $70 million in series B financing in January 2017, adding another $36 million to its coffers in December.
“Future financing activities, including a potential IPO, will be dictated by our progress and data,” Neon Therapeutics CEO Hugh O’Dowd said at the time. “Partnering could bring some important complementary capabilities and assets to our programs, but it is important that the right partners and the right structures are considered to ensure Neon … can remain independent and retain important value-creating rights.”
“This financing ensures that Neon Therapeutics is not dependent on partnering activities to finance its activities,” O’Dowd said at the series B close, adding that the company had no near-term plans to pursue a public offering to gather more funds.
The cancer vaccine field is a particularly tricky one, with a laundry list of candidates showing early promise but proving to be disappointing in the clinic. Argos Therapeutics is one of the latest biotechs to admit failure and abandon a cancer vaccine—it pushed on with its kidney cancer vaccine in spite of advice to give up, eventually dropping the program in April.

Sellas ends Phase 2 cancer med trial early on positive results

Phase 2b trial met key clinical objectives and is being discontinued early by the sponsor
Clinical and regulatory meetings held at the American Society of Clinical Oncology (ASCO) conference
Dr. Jeffrey S. Weber, preeminent immuno-oncology expert, appointed Chairman of Scientific Advisory Board (SAB)
SELLAS Life Sciences Group Inc., (SLS) (SELLAS) today announced that the sponsor-principal investigator, after taking into account that key clinical development objectives were met as well as other regulatory considerations, and in agreement with SELLAS, determined to terminate early the Phase 2b independent investigator-sponsored clinical trial (IST) of trastuzumab (Herceptin®) +/- nelipepimut-S (NeuVax™) in HER2 1+/2+ breast cancer patients. In this Phase 2b study, Herceptin® was provided under a Clinical Trial Supply Agreement by Genentech, Inc.  The decision to early terminate this Phase 2b study was based in part on the previously announced recommendation of the independent Data Safety Monitoring Board (DSMB) to further advance the development of the NeuVax + Herceptin combination for the triple negative breast cancer (TNBC) patient population. Data from the Phase 2b has been submitted for presentation at a major medical conference that will take place during the second half of 2018.
“We wish to thank our patients and their families for their participation in this trial.  Based on data demonstrating that this combination therapy has the potential to become an important therapeutic option for TNBC patients facing a life-threatening disease and for whom current options in the adjuvant setting are extremely limited, we have determined, in consensus with SELLAS, to close out the current study,” stated COL (ret) George E. Peoples, MD, FACS, Founder and Director of Cancer Insight, LLC and study Principal Investigator. “We look forward to supporting SELLAS’ interactions and discussions with regulatory bodies.”
SELLAS conducted this week two advisory meetings with global experts in regulatory affairs and breast cancer clinical development in order to determine the optimal path for further development of the NeuVax + Herceptin combination in TNBC in a pivotal setting and engagement with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
As previously announced, a pre-specified interim analysis of safety and efficacy conducted by the DSMB, demonstrated a clinically meaningful and statistically significant difference between the TNBC cohort of patients and the control arm with a hazard ratio of 0.26, p-value = 0.023, in favor of the NeuVax + Herceptin combination compared to Herceptin alone. The analysis also showed an adverse event profile with no notable differences between treatment arms and no additional cardiotoxicity in the NeuVax + Herceptin arm. Based on these positive results, the DSMB recommended to expeditiously seek regulatory guidance from the FDA for further development of the combination of NeuVax + Herceptin in TNBC, a population with a large unmet medical need.
“We agree with Dr. Peoples’ decision to close this Phase 2b study earlier than planned and it is a priority to advance the development program for NeuVax + Herceptin in TNBC. Indeed, we have initiated the necessary steps for prompt engagement with the regulatory authorities for their guidance on the expeditious development of this combination therapy, as exemplified by the clinical and regulatory advisory board meetings we just conducted during this year’s ASCO meeting,” said Nicholas J. Sarlis, MD, PhD, FACP, Executive Vice President and Chief Medical Officer of SELLAS.

Lannett gets FDA OK for generic of Levaquin


Lannett announced that it received approval from the FDA of its abbreviated new drug application, or ANDA, for Levofloxacin oral solution USP, 25 mg/mL, the therapeutic equivalent to the reference listed drug, Levaquin oral solution, 25 mg/mL, of Janssen Pharmaceuticals. For the 12 months ended April 2018, total U.S. sales of Levofloxacin oral solution USP, 25 mg/mL, was approximately $6M, according to IMS.

Humana started at buy by Citi


Humana coverage resumed with a Buy at Citi. Citi analyst Ralph Giacobbe resumed coverage of Humana with a Buy rating and $340 price target. The analyst continues to see the company as well positioned in an “attractive” Medicare Advantage end market that has “broad demographic/structural tailwinds.” This creates a solid long-term growth profile for Humana and makes the company a “coveted asset and providing valuation support in the least,” Giacobbe tells investors in a research note.

Endo target cut by Deutsche Bank


Deutsche lowers Endo target to $10, keeps Buy rating. Deutsche Bank analyst Gregg Gilbert says that while it is difficult to predict when sentiment on Endo International could improve, the potential exists for greater visibility on some key overhangs over the next year or so. The stock is down 20% year-to-date as U.S. generic market pressures, Vasostrict risk, potential legal liabilities and high leverage continue to weigh on the stock, Gilbert tells investors in a research note. The analyst lowered his price target for Endo to $10 from $12 but keeps a Buy rating on the name. He believes it will be important to see continued stabilization for the generics business and new generic approvals for the stock to work.

CytomX started at buy by SunTrust


CytomX Therapeutics initiated with a Buy at SunTrust. SunTrust analyst Peter Lawson initiated CytomX Therapeutics with a Buy rating and $38 price target. In a research note to investors, Lawson said he is “encouraged” by the biopharma validation of CytomX’s platform, while the company retains ownership of a major part of its pipeline, and believes ASCO and 2H data validates the CX-072 platform for safety and efficacy. Additionally, Lawson contends that 2H data for CX-2009 will validate the company’s strategy of targeting “undruggable” antigens, unlocking two components of CytomX’s valuation. Further, he believes three readouts in 2018 — updated CX-027 data at ASCO, initial Phase 1/2 data from CX-2009 in the second half of the year, and follow-on Phase 1/2 data from CX-072 in the second half — could be positive for the company.