Spectrum Pharma announces publication of positive poziotinib data in cancer cell

Spectrum Pharmaceuticals (NASDAQ:SPPI) announces a publication entitled, “Pan-Cancer Landscape and Functional Analysis of ERBB2 Mutations Identifies Poziotinib as a Clinically Active Inhibitor and Enhancer of T-DM1 Activity.”

In Company’s pre-clinical study of 11 EGFR/HER2 tyrosine kinase inhibitors, poziotinib was the most potent HER2 mutant-selective TKI tested, and was found to be highly active in NSCLC patients with HER2 exon 20 mutations.

Poziotinib is found to be synergistic with a HER2-targeting antibody-drug conjugate, providing a rationale for combinations to move forward into the clinic.

The Company plans to disclose topline data from the first cohort of ZENITH20 study in current quarter. Topline data from cohort 2 is expected by mid-2020.

Spectrum received exclusive license from Hanmi Pharmaceuticals to develop and commercialize poziotinib worldwide, excluding Korea and China.

Shares are up 2% premarket.

https://seekingalpha.com/news/3503957-spectrum-pharma-announces-publication-positive-poziotinib-data-cancer-cell

Value of Juul Labs stakes slashed

Hedge fund Darsana Capital reportedly wrote down its investment in Juul Labs (JUUL) by more than a third.

Sources says the Darsana stake in Juul is now valued at $24B after being valued at $38B a year ago.

Altria’s (NYSE:MO) in Juul stake is estimated to have dropped about 20% since its $12.8B investment. Shares of Altria are up 0.10% premarket to $40.85.

https://seekingalpha.com/news/3503961-value-juul-labs-stakes-slashed

FDA Verdict Ahead For Pfenex’s Osteoporosis Biosimilar

Pfenex Inc PFNX 0.76% has a key binary event coming up: mark your calendar for Oct. 7, when the FDA is scheduled to issue its verdict on the company’s lead drug candidate.
Through its production platform Pfenex Expression Technology, the biotech Pfenex engages in the development of high-value protein-based therapeutics and vaccines.
This thinly traded micro-cap biotech has more than doubled year-to-date. Has the rally run out of steam, or is there further upside ahead?

Clinical Pipeline

The most advanced product candidate in Pfenex’ pipeline, PF708, is inching closer to commercialization.

The lead candidate is a therapeutic equivalent of Eli Lilly And Co LLY 0.3%‘s Forteo, which was approved in 2002 to treat osteoporosis in men and menopausal women who are at high risk of fractures.
Forteo’s global sales stood at $1.6 billion in 2019.
Following the midcycle review of Pfenex’s NDA for PF708 in May, the FDA did not identify any issues requiring an Adcom meeting, the company said in its second-quarter earnings release.
The company is gearing for a commercial launch in the U.S. as early as the fourth quarter of 2019, subject to FDA approval.
Pfenex is also striving to get an “A” therapeutic equivalence designation for PF708 to Forteo, which will allow PF708 to be automatically substituted for Forteo.
The company’s development and licensing partner Alvogen has assumed the responsibility to manufacture and commercialize PF708 in the U.S. at its own expense.
Alvogen has also been granted exclusive rights to market PF708 in the EU, certain countries in the Middle East and North Africa and the rest of the world, excluding those Asian countries for which China NT Pharma has secured the licensing rights.
Pfenex is eligible to receive a gross profit split of up to 60% on product sales from Alvogen, depending on the geography and cost of goods sold.
The company is eligible for double-digit royalties on net sales from NT Pharma.
Alvogen has submitted a Marketing Authorization Application to the European Medicines Agency. Initial comments on the application are expected in the third quarter of 2019.

The Pipeline

Pfenex’s other wholly owned investigational compounds include:
-PF582 (randibizumab), a biosimilar candidate to Lucentis marketed by Roche Holdings AG Basel ADR RHHBY and Novartis AG NVS 1%, indicated to treat retinal diseases.
-PF529, a biosimilar candidate to Amgen, Inc. AMGN 1.8%‘s Neulasta for treating chemotherapy-induced neutropenia.
-PF690, a biosimilar product to Oncaspar, a drug indicated to treat acute lymphoblastic leukemia that’s marketed by Shire, which has been acquired by Takeda Pharmaceutical Co Ltd TAK 1.27%.
-Anthrax vaccine candidates Px563L/RPA563.
-Under partnered programs, Pfenex has PF743, a recombinant crisantaspase and PF745, a recombinant crisantaspase with a half-life extension technology, both produced using its PET platform under an agreement with Jazz Pharmaceuticals PLC JAZZ 1.56%.
PF743, which has been named JZP-458, has completed a Phase 1 study successfully, with Jazz aiming to start a Phase 2/3 study later this year. -Pfenex has development and commercial partnerships for CRM-197, a non-toxic mutant of diphtheria toxin, which functions as a carrier for polysaccharides and haptens, making them immunogenic.
It has commercial agreements in place with Merck & Co., Inc. MRK 1.33% and the Serum Institute of India, or SII.
Merck is using CRM197 in 12 Phase 3 studies for its V114, an investigational 15-valence conjugate vaccine for the prevention of pneumococcal disease.
SII has a 10-valence pneumococcal conjugate vaccine, Pneumosil, which utilizes CRM197. SII has initiated the process of World Health Organization prequalification for Pneumosil in the first quarter of 2019, with the process likely taking upto a year.

Competition

Apart from the $1.6 billion in sales netted by Eli Lilly, Radius Health Inc RDUS 2.56%‘s Tymlos, another approved osteoporosis drug, posted sales of $100 million, taking the total sales of osteoporosis drugs to $1.7 billion last year.
Pfenex may also have to brace for additional competition, as Evenity developed by Amgen, Inc. AMGN 1.8% and Belgian biotech UCB has been given the nod in the U.S. for treating osteoporosis in menopausal women at a high risk of fracture, although the EU has yet to approve the drug.
Osteoporosis product sales are expected to reach $6.7 billion in the U.S., Japan and the five major European markets by 2025. About 53 million Americans either have osteoporosis or are at increased risk, Pfenex said, citing NIH estimates.

Financials

Revenue recognized by Pfenex is through collaboration agreements, licensing agreement, government contracts and sales of reagent protein products.
A majority of the company’s 2018 revenues were derived from its collaboration agreement with Jazz and from its advanced development contract with BARDA, with each accounting for over 10% of its total revenues. Source: 10-Q Filing
For the three months ended June 30, 2019, the company reported revenue of $2.81 million, down from $4.19 million year-over-year.
The loss per share narrowed from 41 cents to 24 cents, as R&D expenses declined about 55%. Cash and cash equivalents stood at $41.62 million as of June 30.

Upcoming Catalysts

• Oct. 3: Presentation at the Cantor Healthcare Conference.
• Oct. 7: PDUFA Date For PF708.
• Commercial launch of PF708: as early as the fourth quarter of 2019 (contingent on FDA approval). Licensee Jazz to initiate Phase 2/3 study of PF743 (JZP-458): later this year.
• Potential sales royalty payments for the Serum Institute of India’s Pneumosal: as early as the first quarter of 2020, when the WHO prequalification process is complete.

Stock Take

Pfenex, which went public in July 2014 through an 8.33-million-share IPO priced at $6 per share, rose to a post-IPO high of $24.41 in a year.
The stock then went downhill, troughing at $2.07 in December 2017 before attempting a modest recovery that took it to a peak of $8.42 in mid-2018.
Thereafter, it has been more of a consolidation move. The stock has traded in a 52-week range of $3.13-$10.20.
Source: Y Charts
From an near-term intraday low of $5.65 on Aug. 5, Pfenex shares rallied to a high of $10.20 on Sept. 17, a peak-trough gain of roughly 81%.
The catalyst for the recent rally has been the kickoff of a $17-million development milestone payment from Jazz for PF745.
The 50-day SMA has not been violated to the downside by the stock since early August, with the measure currently at $7.448.
Buying could emerge if the stock drops back to this level. The $7.20-$7.30 region served as resistance for the stock since the middle of May before buying pushed the stock past this resistance in early September.
If this resistance-turned support level breaks down, the next support could be around $5.40-$5.50, a low from which the stock has bounced a few times in recent months.
On the contrary, the stock could revisit its recent highs around $9.70-$10.20 on a potentially favorable reaction to the PDUFA catalyst.
Pfenex’s pipeline optionality and a steady stream of milestone payments from partnered programs and collaborations could cushion the stock even in the wake of an adverse outcome.
In early September, JMP Securities analyst Jason Butler upgraded shares of Pfenex from Market Perform to Outperform and raised the price target from $13 to $17, suggesting over 100% upside potential.
https://www.benzinga.com/general/biotech/19/10/14527152/biotech-stock-on-the-radar-fda-verdict-ahead-for-pfenexs-osteoporosis-biosimilar

MEI Pharma +16.7% on updated early-stage trial data

MEI Pharma (NASDAQ:MEIP) has risen another 16.7% postmarket after citing updated clinical data from an early-stage trial.

The company announced data from an ongoing Phase 1b study of investigational ME-401 in patients with indolent B-cell malignancies.

It will present the data at the company’s investor and analyst event, starting tomorrow at 8 a.m. ET.

The company will also review progress across the pipeline of its four clinical-stage oncology candidates, with a focus on voruciclib, a cyclin-dependent kinase inhibitor with potent CDK9 inhibition.

https://seekingalpha.com/news/3503880-mei-pharma-plus-16_7-percent-updated-early-stage-trial-data

J&J’s Janssen gets breakthrough status for niraparib in prostate cancer

The U.S. Food and Drug Administrations grants Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical unit a breakthrough therapy designation for niraparib, an orally administered PARP inhibitor for the treatment of patients with a certain type of prostate cancer and who have already been treated with taxane chemotherapy and androgen receptor-targeted therapy.

JNJ gains 1.0% in after-hours trading.

The poly ADP-ribose polymerase inhibitor is being studied to treat patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer. BRCA1/2 mutations are the most common DNA-repair gene defects (DRD) in patients with mCRPC.

The designation is based on data from the Galahad study, a Phase 2, multicenter, open-label clinical trial evaluating the efficacy and safety of niraparib in the treatment of adult patients with mCRPC and DRD who had received treatment with next-generation androgen-receptor targeting therapies and docetaxel.

https://seekingalpha.com/news/3503876-j-and-js-janssen-gets-breakthrough-designation-niraparib-prostate-cancer

Nutritionists see red over study downplaying health risks of red meat

Put down the T-bone and slowly back away from that side order of ribs.
Nutritionists across the country are hitting back hard after a new collection of studies alleged that red meat and processed meats — including steak, ribs, bacon and salami — are fine for your health after all.

‘They ignored major parts of the available evidence.’

—Harvard University professor Walter Willett, who has published 1,700 academic articles on nutrition and public health

“Totally bizarre,” Harvard University professor Walter Willett told MarketWatch. “It really displays ignorance. They ignored major parts of the available evidence.”
He was speaking after the Annals of Internal Medicine, a publication of the American College of Physicians, this week published a collection of five studies that contradicted decades of growing consensus about the health risks of red meat, including pork, and processed meats.
The studies didn’t actually say that red meat was good for you — they just argued that the evidence they were bad for you was weak.
It concluded: “Low- to very-low-certainty evidence suggests that diets restricted in red meat may have little or no effect on major cardiometabolic outcomes and cancer mortality and incidence.”

But Willett said it made no sense to include red meat in good health recommendations. “People [also] like to smoke,” he said. “They like to drink sugared soft drinks, they like to have unsafe sex.”

Willett is professor of nutrition and epidemiology at Harvard’s T.H. Chan School of Public Health. He’s chaired Harvard’s department of nutrition for more than two decades and has published 1,700 academic articles in the field.
He said avoiding red meat can slash the risks of diabetes and the risk of dying young. A drug that did as much for your health, he said, “would be a blockbuster. It would make tens of billions of dollars.”
McDonald’s MCD, +1.82% and Burger King QSR, +1.09% have recently introduced alternative options to beef. McDonald’s has a burger using Beyond Meat BYND, +1.49%, while Burger King has the Impossible Burger.
The Physicians Committee for Responsible Medicine, a nonprofit medical advocacy group, on Tuesday filed a petition with the Federal Trade Commission to rebut many of the claims made in the study. Neal Barnard, the PRCM president, slammed the study’s authors for “misrepresentations,” “an inaccurate statement of the findings,” and “a major disservice to public health.”
Gordon Guyatt, professor of medicine at McMaster University in Canada and one of the study’s authors, said the reaction “has reached levels I would call hysteria.” He compared the nutrition establishment to the Hans Christian Anderson tale, the Emperor’s New Clothes. “If you’re the emperor, and somebody points out that you haven’t any clothes, this is not going to be a very appealing situation,” he added. “It’s very threatening, and people are defending their territory.”

‘It’s a form of patriarchy if we just tell people they should eliminate or reduce their meat consumption.’

—Bradley Johnston, one of the authors of the latest study

Bradley Johnston, one of the study’s authors, an associate professor of community health and epidemiology at Dalhousie University in Halifax, Nova Scotia, told USA Today: “It’s a form of patriarchy if we just tell people they should eliminate or reduce their meat consumption. We don’t believe that there should be broad public health recommendations, almost like scare tactics, for the population as a whole.”
“Based on these reviews, we cannot say with any certainty that reducing red meat or processed meat will prevent cancer, diabetes or heart disease,” he added.
The American Heart Association, the American Cancer Society, and others also joined the backlash. The American College of Cardiology said it was “alarmed by the reckless dietary recommendations” In 2015, the International Agency for Research on Cancer’s Monograph panel, which is part of the World Health Organization, voted on the issue and concluded that red meat was “probably carcinogenic to humans.”
In response to that landmark decision, the North American Meat Institute, a trade group for the industry, said that vote classifying red and processed meat as cancer hazards “defies both common sense and numerous studies showing no correlation between meat and cancer and many more studies showing the many health benefits of balanced diets that include meat.”
The battle between the two sides of this debate, as this explainer at news site Vox shows, involves technical disputes about how to construct scientific studies in the real world, and which ones are more reliable, and why. The limitation of all these studies is that they’re all flawed.
It’s not possible to control for all variables, unless the participants were confined to a laboratory for years, if not decades. That’s why researchers frequently caution readers that their conclusions suggest correlation rather than causation.
All such studies naturally have theoretical flaws, says Jane Uzcategui, professor of nutrition and food studies at Syracuse Universities. But the observational studies about the risks of red meat are so many, and so big, that we should give them a lot of weight, she adds.
“The fact that we’ll never have any better evidence does not make it good evidence,” adds Guyatt.
All findings that challenge a consensus generate a backlash. The latest study is the work of 14 researchers from seven countries.
The researchers aren’t without allies. Stanford University medical professor John Iannodis told Vox’s Julia Belluz that the latest study was “very rigorous and unbiased.”
He added, “These papers provide a nice counterbalance to the current norm in nutritional epidemiology where scientists with strong advocacy tend to overstate their findings and ask for major public health overhauls even though the evidence is weak.”
https://www.marketwatch.com/story/nutritionists-see-red-over-study-downplaying-the-health-risks-of-red-meat-2019-10-02

Injection-site opponents say ruling doesn’t mean they’re through

A landmark ruling Wednesday paved the way for a supervised injection site in Philadelphia. While advocates won this battle, opponents say the war isn’t over.
More than 1,100 people died from overdoses in Philadelphia last year. Opioids were involved in the vast majority of them.
The city says offering a space for those who suffer from addiction to use will save lives. But the federal government and many neighbors do not want it.
Had the judge ruled in favor of the federal government, supervised injection sites would have been dead in the water. But plans to open one in Philadelphia are now moving forward.
Philadelphia has one of the highest overdose rates of any major city in the country, and Kensington is ground zero for the opioid epidemic.
“It’s a mess,” Bernadette Sterling said.

Sterling has lived near Kensington Avenue and East Cambria Street for more than four decades. She says not a single day passes where she’s not reminded of the crisis.
“It’s nothing. It’s like walking zombies,” she said.
Even seeing the problem firsthand, Sterling says she’s not in favor of so-called safe injection sites, where people can use heroin while medical staff stand by with the overdose reversal drug Naloxone.
“I don’t support any of this,” Sterling said.
But those supervised injection sites could soon open up.
A federal judge ruled Wednesday that the facilities do not violate federal law.
“It is the first of its kind in the United States,” Linda Dale Hoffa, a law partner at Dilworth Paxon LLP, said.
Hoffa, a former federal prosecutor, explains the government argued Philadelphia’s plans violated a part of the U.S. Controlled Substances Act, which is also known as the Crackhouse Law.
“The United States Attorney says operating a safe injection site where they will facilitate the use of illegal drugs is the same as operating a crackhouse,” Hoffa said.
But Judge Gerald McHugh says the intent of the 1986 bill is very different than what is being proposed with Philly’s plan.
“The judge said there is a different purpose going on here, and the purpose of the safe injection site is to help,” Hoffa said.

“I can see both sides,” a community activist named Bernard said.
Bernard volunteers his time picking up used needles. He knows neighbors are concerned, but he believes the injection sites would provide immediate access to treatment and a way to help slow such a devastating problem.
“It’s got to go in somebody’s neighborhood,” Bernard said. “It’ll be in Kensington somewhere.”
U.S. Attorney William McSwain, an appointee of Republican President Donald Trump, had gone to court in Philadelphia to try to block the plan, calling the goal “laudable” but supporters misguided.
“Today’s opinion is merely the first step in a much longer legal process that will play out. This case is obviously far from over. We look forward to continuing to litigate it, and we are very confident in our legal position,” McSwain said.
Based on that statement, it’s safe to say the decision will likely be appealed and therefore, there is no timeline on when a supervised injection site could open.

Judge Rules Proposed Supervised Injection Site In Philadelphia Doesn’t Violate Federal Law