FDA Issues Tobacco Regulations

FDA ‘providing targeted relief’ on some tobacco regulation timelines

FDA announces new 'comprehensive plan' for tobacco, nicotine regulation. See Stockwinners.com Market Radar

The U.S. Food and Drug Administration announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death.

As part of the plan, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products.

The agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive.

The agency plans to issue this guidance describing a new enforcement policy shortly.

The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts.

Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022.

Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

WHAT’S NEW

The FDA announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to “better protect kids and significantly reduce tobacco-related disease and death.”

The approach shifts focus to nicotine and the issue of addiction as the center of the agency’s tobacco regulation efforts. The aim, according to the agency, is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.

Commenting on the matter, FDA commissioner Scott Gottlieb said, “Unless we change course, 5.6M young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”

TOBACCO STOCKS FALL

Publicly traded companies in the tobacco products space include Altria Group (MO), British American Tobacco (BTI), Philip Morris (PM) and Reynolds American (RAI). Altria Group is down 5% on the news.

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When It Rains, It Pours

Insurers are dropping Valeant’s top products

Insurers are dropping Valeant's top products. See Stockwinners.com Market Radar

The beleaguered pharmaceutical firm sees its products being denied coverage by major health insurers.

United Healthcare’s (UNH) formulary is no longer covering Valeant Pharmaceuticals’ (VRX) number three branded drug Solodyn and will also now exclude Retin-A brand, its number four branded drug, Wells Fargo analyst David #Maris tells investors in a research note.

The analyst estimates the two drugs represented approximately $214M of Valeant’s sales in 2016. Maris also points out that #Glumetza, Valeant’s number eight branded drug, and Relistor were removed in July from CVS/Caremark’s (CVS) formulary.

These two drugs had approximately $119M in 2016 revenues. Maris notes his counterpart Peter Costa estimates that United Healthcare covers approximately 17% of the U.S. and CVS covers approximately 33%.

Express Scripts (ESRX) is releasing its 2018 national formulary next week, Costa adds.

Maris keeps an Underperform rating on shares of Valeant with a $9 price target. The stock closed on Thursday at $17.13.

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AstraZeneca receives $8.5 Billion from Merck

AstraZeneca receives $1.6B upfront in oncology collaboration with Merck

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AstraZeneca (AZN) and Merck (MRK) announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca’s Lynparza for multiple cancer types.

#Lynparza is an oral poly ADP ribose polymerase, or PARP, inhibitor currently approved for BRCA-mutated #ovarian cancer in multiple lines of treatment.

The companies will develop and commercialize Lynparza jointly, both as monotherapy and in combination with other potential medicines.

Independently, the companies will develop and commercialise Lynparza in combination with their respective PD-L1 and PD-1 medicines, Imfinzi and Keytruda.

The companies will also jointly develop and commercialize AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase pathway, currently being developed for multiple indications including thyroid cancer. Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialization costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities.

Gross profits from Lynparza and selumetinib Product Sales generated through monotherapies or combination therapies will be shared equally.

Merck will fund all development and commercialization costs of Keytruda in combination with Lynparza or selumetinib. AstraZeneca will fund all development and commercialization costs of #Imfinzi in combination with Lynparza or selumetinib. AstraZeneca will continue to manufacture Lynparza and selumetinib.

As part of the agreement, Merck will pay AstraZeneca up to $8.5B in total consideration, including $1.6B upfront, $750M for certain license options and up to $6.15B contingent upon successful achievement of future regulatory and sales milestones.

Under the terms of the agreement, AstraZeneca anticipates approximately $1B to be recorded under Externalization Revenue in 2017.

OTHER EVENTS

AstraZeneca plunged in pre-market trading as Phase III MYSTIC trial endpoint not met. AstraZeneca announced progression-free survival results for the Phase III #MYSTIC trial, a randomized, open-label, multi-center, global trial of Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic 1st-line non-small cell lung cancer.

MYSTIC TRIAL:

AstraZeneca has announced progression-free survival, or PFS, results for the Phase III MYSTIC trial, which is testing Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic first line non-small cell lung cancer.

The combination did not meet the primary endpoint of improving PFS compared to standard-of-care in patients whose tumors express PD-L1 on 25% or more of their cancer cells.

PRICE ACTION

In Thursday’s trading, shares of AstraZeneca have dropped over 15% to $28.72, while Bristol’s (BMY) stock has slipped almost 5% to $53.23. MYSTIC trial failure is a negative read-through for Bristol-Myers’ combo of Opdivo + Yervoy in the ongoing CheckMate-227 trial.

Meanwhile, Merck is up over 3% to $63.75.

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Watch Tetraphase!

Tetraphase announces positive top-line results from Phase IGNITE4 trial

Tetraphase announces positive top-line results from Phase3. See StockwinnersTetraphase Pharmaceuticals (TTPH) announced positive top-line results from #IGNITE4, the company’s phase 3 clinical trial evaluating the efficacy and safety of twice-daily intravenous #eravacycline compared to meropenem for the treatment of patients with complicated intra-abdominal infections.

Tetraphase Pharmaceuticals, Inc. develops various antibiotics for the treatment of serious and life-threatening multidrug-resistant infections. Its lead product candidate is eravacycline, an intravenous and oral antibiotic for use as a first-line empiric monotherapy to treat resistant and multidrug-resistant infections, including multidrug-resistant Gram-negative infections.

Meropenem, sold under the brandname Merrem among others, is an broad-spectrum antibiotic used to treat a wide variety of infections.

It gained US FDA approval in July 1996. It was initially marketed by AstraZeneca (AZN). It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.

Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin.

The results of #IGNITE4, which enrolled 500 patients, demonstrated statistical non-inferiority of eravacycline to meropenem for the primary efficacy endpoint of clinical response at the test-of-cure visit.

Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin.

PRICE RANGE

TTPH closed Tuesday’s trading at $6.90. It traded as high of $8.72 in extended trading. Shares have a 52-weeks trading range of $3.11 – $9.93.

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India Approves Anika Therapeutics’ Treatment for Osteoarthritis Pain

Anika Therapeutics says Monovisc approved in India

Anika Therapeutics says Monovisc approved in India. See Stockwinners.com Market Radar for Stock Upgrades, stock downgrades, stock earnings, stocks to watch

Anika Therapeutics (ANIK) announced that regulatory authorities in India granted approval to MONOVISC, its single injection viscosupplement for the treatment of pain associated with osteoarthritis of all human synovial joints.

#MONOVISC is commercially available in the United States, Canada and Europe, and Anika plans to expand into India, Australia, New Zealand and additional international markets over the next six to nine months.

“Expanding our global commercial footprint is one of our key strategic pillars of growth, and the approval of MONOVISC in India is a proof point for our ability to execute against the benchmarks we define each year,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer of Anika Therapeutics.

“There is a growing demand for non-invasive, long-acting treatments for osteoarthritis in emerging countries such as India where knee replacement surgery is often the last option or not an option at all, due to limited medical resources outside major cities and high costs of surgery and postsurgical care.

With its ability to safely relieve pain for up to six months with fewer office visits, lower treatment costs and no downtime after treatment, MONOVISC is poised to be well-received by physicians and patients in India.”

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Nektar Gets $150 Million from Eli Lilly

Eli Lilly and Nektar announce collaboration to develop NKTR-358

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Eli Lilly and Company (LLY) and Nektar Therapeutics (NKTR) have announced a strategic collaboration to co-develop NKTR-358, a novel immunological therapy discovered by Nektar.

NKTR-358, which achieved first human dose in Phase 1 clinical development in March, has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

Under the terms of the agreement, Nektar will receive an initial payment of $150M and is eligible for up to $250M in additional development and regulatory milestones.

The parties will share Phase 2 development costs 75% Lilly and 25% Nektar.

Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis.

Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization.

Nektar will have an option to co-promote in the U.S. under certain conditions. This transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

Lilly expects to incur an acquired in-process research and development charge to earnings in 2017 of approximately 9c per share. The company’s reported EPS guidance in 2017 is expected to be reduced by the amount of the charge. There will be no change to the company’s non-GAAP EPS guidance as a result of this transaction.

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NeuroDerm Sold for $1.1 Billion Cash

NeuroDerm agrees to be acquired by Mitsubishi Tanabe Pharma for $39 a share

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NeuroDerm (NDRM) announced that it has signed a definitive agreement under which Mitsubishi Tanabe Pharma will acquire NeuroDerm for $39 per share in cash.

The transaction has received unanimous approval by NeuroDerm’s board and implies an equity value of approximately $1.1B.

NeuroDerm Ltd. engages in developing drug-device combinations for the treatment of central nervous system (CNS) disorders. The company’s levodopa and carbidopa (LD/CD) product candidates, which have completed Phase IIa clinical trial, include ND0612L and ND0612H for the treatment of patients with moderate and advanced Parkinson’s disease.

The offer of $39 per share in cash represents a premium of 79%over the unaffected price on June 9 of NeuroDerm’s ordinary shares on the Nasdaq Stock Market and a 17% premium over the closing stock price on July 21.

A special meeting of shareholders to approve the transaction is expected to be held this fall. Assuming typical regulatory and shareholder approval timeframes, NeuroDerm currently anticipates the transaction will close in Q4.

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Humira Approved for Pediatric Patients with AU

AbbVie receives CHMP positive opinion for Humira for pediatric patients with AU

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AbbVie (ABBV) said that the European Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for #HUMIRA for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

The #CHMP opinion is based on results from the SYCAMORE clinical trial, a randomized controlled study of the clinical effectiveness and safety of HUMIRA combined with methotrexate versus methotrexate plus placebo for the treatment of active JIA-associated uveitis.

It was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool.

The Independent Data Safety and Monitoring Committee recommended unmasking the trial early after 90 randomized patients with active JIA-associated uveitis showed that HUMIRA combined with methotrexate controlled ocular inflammation better and was associated with a significantly lower rate of treatment failure than placebo.

The review of the marketing authorization application is being conducted under the centralized licensing procedure.

A marketing authorization decision is anticipated by September.

If approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

HUMIRA was approved by the European Medicines Agency for the treatment of non-infectious intermediate, posterior and panuveitis in adults in June 2016.

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Zynerba is Worth Watching

Watch Zynerba ahead of trial data on its its ZYN002 for in adult epilepsy patients

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With #Zynerba Pharmaceuticals (ZYNE) expected to release data from a Phase 2 trial over the next several weeks,#Jefferies analyst Biren #Amin recently argued that a positive update could lead the shares north of $65-$75. However, a lack of treatment effect could drop the stock to $4-$5.

CANNABIDIOL GEL

Over the coming weeks, Zynerba is expected to announce data from its ZYN002 #cannabidiol, or #CBD, gel Phase 2 STAR 1 trial in adult epilepsy patients with refractory focal seizures.

ZYN002 is a synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery.

BINARY EVENT

In a research note to investors, Jefferies’ Amin pointed out that the STAR-1 trial represents a “critical catalyst” for Zynerba as it provides the first proof of concept for transdermally delivered CBD.

Given investors naturally compare the program to GW Pharmaceuticals’ (GWPH) #Epidiolex, and oral CBD, the analyst believes a better comparison would be to therapies tested in patients with partial-onset seizures who are uncontrolled on their current therapy.

Additionally, Amin noted that while the study is designed for a 20% treatment effect over a placebo, an effect greater than 15% could be considered clinically relevant. A key question that remains unanswerable is the extent of activity observed with ZYN002 given this is the first study evaluating efficacy in epilepsy patients, he contended.

He told investors that positive data could lead to shares north of $65-$75, but a lack of treatment effect could drop shares to $4-$5. The analyst assumes ZYN002 is successfully developed and launched for refractory epilepsy in 2019.

Amin reiterated a Buy rating and a $32 price target on the shares.

PRICE ACTION

In Thursday’s trading, shares of Zynerba dropped 2% to $18.81. Over the last month the stock is up 10%, but over the last three months it has declined nearly 24%.

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Stocks to Watch – Ironwood Pharmaceuticals

Ironwood IW-3718 Phase IIb trial meets primary endpoint

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Ironwood Pharmaceuticals (IRWD) announced positive top-line data from a Phase IIb clinical trial evaluating IW-3718 in adult patients with uncontrolled #gastroesophageal #reflux disease.

The trial met its primary endpoint, indicating that twice-daily, oral dosing of IW-3718 1500 mg plus a proton pump inhibitor significantly reduced heartburn severity in patients with uncontrolled GERD compared to patients treated with a PPI alone.

Further, more than half of patients treated with IW-3718 1500 mg plus a PPI achieved a clinically meaningful reduction in heartburn severity. IW-3718 1500 mg was well tolerated in the trial.

#Ironwood plans to have end of Phase II meetings with the U.S. Food and Drug Administration, after which the company expects to advance IW-3718 1500 mg into Phase III development in 2H18.

#IW-3718 is a novel formulation of a bile acid sequestrant designed to release in the stomach over an extended period of time, bind to bile that refluxes into the stomach, and potentially provide symptomatic relief in uncontrolled GERD.

Data from the Phase IIb trial showed a dose response across the primary and key secondary endpoints, with the most pronounced response observed at the highest dose of IW-3718 studied. Top-line data were as follows: Percent Change from Baseline to Week 8 in Weekly Heartburn Severity: patients treated with IW-3718 1500 mg plus a PPI showed a mean decrease of 58% from baseline in heartburn severity compared to 46% in patients treated with a PPI alone.

Clinically Meaningful Degree of Improvement in Weekly #Heartburn Severity: a 45% reduction in weekly heartburn severity was determined to be clinically meaningful for patients in this study based on patient-reported outcome measures.

Heartburn Responder: a heartburn responder was defined as a patient who experienced at least a 45% reduction from baseline in heartburn severity for at least four out of eight weeks, including at least one of the last two weeks. 52.9% of patients treated with IW-3718 1500 mg plus a PPI were heartburn responders, compared to 37.1% of patients treated with a PPI alone.

Percent Change from Baseline to Week 8 in Weekly Regurgitation Frequency: patients treated with IW-3718 1500 mg plus a PPI showed a mean decrease of 55.4% from baseline in regurgitation frequency compared to 37.9% in patients treated with a PPI alone. There were no treatment-related serious adverse events reported with IW-3718 1500 mg.

SIDE EFFECTS

The most common adverse event reported overall was constipation, which was reported in 7.4% of patients on IW-3718 1500 mg plus a PPI compared to 7.1% of patients on a PPI alone. All constipation adverse events reported were mild or moderate in severity.

Discontinuation rates due to adverse events were less than 5% and similar across treatment groups.

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Vertex Higher on its Cystic Fibrosis Drug

Vertex jumps after ‘wowing’ analysts with cystic fibrosis data

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Shares of Vertex (VRTX) are on the rise after the company reported positive data from Phase 1 and Phase 2 studies of three different triple combination regimens in people with cystic fibrosis who have one #F508del mutation and one minimal function mutation.

Reacting to the news, several Wall Street analysts upgraded the stock to buy-equivalent ratings and raised their price targets on the shares.

BUY VERTEX

In a research note to investors this morning, Janney Capital analyst Debjit Chattopadhyay upgraded Vertex to Buy, stating that the Phase 2 data for its three triple combination programs in CF were “significantly above the most optimistic expectations.”

The analyst argued that the quality of the data should allow Vertex to potentially accelerate commercialization under the “New FDA” and importantly sets the bar very high for competition. Citing its “potential dominance of CF,” Chattopadhyay said he thinks Vertex becomes the “most logical large-cap M&A target.”

Chattopadhyay was not the only analyst upgrading the stock this morning.

His peer at Cowen also upgraded Vertex to Outperform, saying efficacy data from its triple regimens showed “breakthrough-quality” results, and will very likely “dramatically” improve the quality of life and extend the life span of 80% of the 75K patients with CF worldwide.

Phil Nadeau pointed out that he expects a launch in 2021 and $10B in franchise sales in 2025. The analyst raised his price target on the shares to $200 as he sees a 10-year path of revenue growth for Vertex.

Meanwhile, Barclays analyst Geoff Meacham told investors that he thought the Phase 2 data in CF was an “unequivocal success and constitutes a major de-risking event.” Citing more confidence in the viability of the triple combo and the likely accelerated development path, the analyst upgraded Vertex to Overweight and raised his price target on the stock to $180.

Also this morning, Raymond James analyst Laura Chico upgraded Vertex to Outperform, with a $181 price target, citing the “compelling” efficacy data for its triple-combo CF regimens.

WOW: JPMorgan analyst Cory Kasimov began his research note with “Wow. Just wow,” following last night’s data release from Vertex.

To say that the initial results for Vertex’s triple combinations beat expectations would be an understatement, Kasimov told investors, adding that the data not only sets up well to reach a large majority of the CF patient population, but also greatly increases the competitive hurdle while also enhancing the scarcity value of the company. He raised his price target on the shares to $175 and reiterated an Overweight rating on the name.

Credit Suisse, Stifel, Citi and Piper Jaffray also raised their price targets on the stock following the data release.

OTHERS TO WATCH

Competitor Galapagos (GLPG) is sliding in morning trading following Vertex’s CF data announcement.

However, commenting on the news, H.C. Wainwright analyst Andrew Fein said the data may also be “encouraging” in a roundabout way for Galapagos and another smaller company exploring an add-on to a CF doublet combo, Proteostasis (PTI).

If increasing the dosing of the Vertex compounds does not differentiate them further in efficacy, then this consistency in benefit “may truly be a class phenomenon,” and similar results should be expected from any competitor add-on agent out there, he suggested.

PRICE ACTION

In Wednesday’s trading, shares of Vertex (VRTX) have gained about 22% to $161.26, while Galapagos and Proteostasis have dropped over 4% and 3%, respectively.

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Watch Nektar Therapeutics on its Opioid Painkiller

Nektar says NKTR-181 shows ‘significantly less abuse potential’ than oxycodone

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Nektar Therapeutics (NKTR) announced topline results from an oral Human Abuse Potential study of #NKTR-181, an opioid analgesic that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids.

The NKTR-181 HAP study was designed to confirm and assess the relative oral abuse potential of NKTR-181 at its maximum analgesic or therapeutic dose of 400 mg and at a supratherapeutic dose of 3 times to 12 times greater than its analgesic dose range of 100 mg to 400 mg compared to common therapeutic doses of a Schedule II opioid, oxycodone.

In the study, NKTR-181 400 mg had a significantly lower rating of peak liking compared to oxycodone 40 mg; NKTR-181 400 mg had a significantly lower rating of peak liking compared to oxycodone 60 mg; NKTR-181 600 mg had a significantly lower rating of peak liking compared to oxycodone 40 mg; NKTR-181 600 mg had a significantly lower rating of peak liking compared to oxycodone 60 mg; and NKTR-181 1200 mg had a significantly lower rating of peak drug liking compared to oxycodone 60 mg.

This dose was not statistically different from #oxycodone 40 mg, the company said.

Ivan #Gergel, Chief Medical Officer of Nektar, said, “It is clear from our new study results that NKTR-181 is highly differentiated in this respect from oxycodone, which is a choice drug of abuse.

Further, and critically important in the context of this public health emergency, NKTR-181’s less rewarding properties and strong analgesia are inherent to its novel molecular structure and independent of any abuse-deterrent formulation…We are committed to bringing this new pain treatment to patients and physicians as quickly as possible.”

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Stocks to Watch: Puma Biotechnology

Puma Biotechnology confirms FDA approval of NERLYNX for treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer

 

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Puma Biotechnology announced that the U.S. FDA has approved #NERLYNX (neratinib), formerly known as #PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.

Puma expects neratinib to become commercially available in September 2017 and to be marketed as NERLYNX.

Puma Biotechnology said up to one in four patients experience recurrence after treatment, but studies of its drug showed a 34% reduction in recurrence.

“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,” Richard Pazdur, director of the FDA Oncology Center of Excellence.

“Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”

See our previous blogs on Puma and its progress toward the approval.

STOCK PRICE

On May 11, 2017 when PBYI was trading at $30.75, Stockwinners predicted that Puma stock will double by the end of May.  PBYI closed at $86.10 on Monday. It has a 52-week trading range of $28.35 – $94.70.

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Stocks to Watch: Paratek Pharmaceuticals Study Meets EndPoint

Paratek study meets primary, secondary FDA, EMA efficacy endpoints

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Paratek Pharmaceuticals (PRTK) announced positive top-line results from a pivotal Phase 3 clinical study comparing its once-daily, oral investigational antibiotic, omadacycline, to twice-daily oral linezolid in the treatment of acute bacterial skin and skin structure infections.

The study met all of its primary and secondary endpoints required to support approval for this indication by the U.S. Food and Drug Administration and the European Medicines Agency.

This represents the third positive Phase 3 registration study of omadacycline.

“This successful study demonstrates the potential of an oral-only dosing regimen of omadacycline, which would enable treatment in the outpatient setting and potentially reduce the need for admission to the hospital,” said Michael Bigham, Chairman and Chief Executive Officer of Paratek.

“The utility of the oral only dosing regimen represents a significant potential benefit to patients and prescribers who are in need of new, effective oral agents to combat serious community-acquired infections.”

The pivotal Phase 3 clinical study known as #OASIS-2 evaluated the efficacy and safety of once-daily, oral-only omadacycline compared to twice-daily, oral-only linezolid in 735 adults with ABSSSI.

#Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority in the modified intent-to-treat population compared to linezolid at the early clinical response 48 to 72 hours after the first dose of study drug.

The ECR rate for omadacycline was 87.5% compared to 82.5% for linezolid.

Additionally, omadacycline met statistical NI compared to linezolid for the EMA-specified co-primary endpoints at the post therapy evaluation, 7 to 14 days after completion of therapy in the mITT and the Clinically Evaluable populations.

Clinical success rates at PTE in the mITT population for the omadacycline and linezolid arms were 84.2% vs. 80.8%, respectively; and in the CE population were 97.9% vs. 95.5%, respectively.

Omadacycline demonstrated high clinical success rates for infections caused by the most common #ABSSSI pathogens, including methicillin-resistant Staphylococcus aureus.

STOCK PRICE

PRTK last traded at $24.95. Stock has a 52-week trading range of $9.80 – $26.10.

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TherapeuticsMD Tumbles on FDA Update

TherapeuticsMD drops as TX-004HR update seen not reading ‘well at all’

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Shares of TherapeuticsMD (TXMD) plunged in pre-market trading on Monday after the company provided a regulatory update on the status of its New Drug Application for TX-004HR.

REGULATORY UPDATE

In a statement, TherapeuticsMD provided an update on the status of its NDA for TX-004HR, its investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse, saying that it participated in a Type A Post-Action Meeting on June 14 with the FDA’s Division of Bone, Reproductive, and Urologic Products.

At the meeting, the two sides discussed the complete response letter that TherapeuticsMD previously received for the NDA, which also allowed the company to present new information it believes could address concerns raised in the letter and “positively” impact the status of the NDA.

TherapeuticsMD said it has formally submitted the new information for consideration per the FDA’s request.

However, the company noted that while it continues to have “productive” dialogue with the FDA related to its review, it has not yet received a formal timeline for a conclusion of this review.

#TherapeuticsMD said it “looks forward” to working with the FDA to address its concerns and sees further clarity on the pathway forward for the NDA “in the coming weeks,” adding that it “reserves the right to pursue the FDA’s formal dispute resolution process if a reasonable timeline to address such concerns cannot be established.”

WHAT’S NOTABLE

On May 8, TherapeuticsMD said it received the CRL from the FDA regarding the TX-004HR NDA.

At the time, the company said it planned to meet with the FDA as soon as possible to address the concerns raised in the letter, which involved “the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal phase 3 Rejoice Trial.”

Adam #Feuerstein, who previously wrote about biotech stocks for TheStreet and currently is a senior writer for StatNews, tweeted in May that the company lacks the cash to conduct the type of safety study of TX-004HR requested by the FDA, without cutting expenses or raising more money, adding that a delay for this product “could be fatal” for the company.

Feuerstein tweeted this morning that TherapeuticsMD’s regulatory update on resolving the CRL “does not read well at all.”

ANALYST COMMENTARY PRIOR TO UPDATE

Oppenheimer analyst Jay Olson upgraded TherapeuticsMD to Outperform recently ahead of the FDA meeting update, and said there was a “reasonable probability” of positive news.

Olson argued that data on complete response letters provides confidence that there are likely no other TX-004HR approvability issues besides lack of long-term endometrial safety data beyond the 12 weeks studied in REJOICE and that there are likely no approvability issues that would have any implications for TX-001HR.

PRICE ACTION

In pre-market trading on Monday, TherapeuticsMD is down 12%.

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The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.