Thermo Fisher buys Henogen for nearly $880 million in gene therapy expansion

 Thermo Fisher Scientific Inc said on Friday it completed its 725 million euros ($879.72 million) acquisition of Belgium-based Henogen SA that will help strengthen the medical device maker’s position in the fast-growing field of gene therapy manufacturing.

Henogen, a unit of contract manufacturing services provider Novasep, manufactures viral vectors that are frequently used in gene therapies to deliver genetic materials into defective cells.

“Viral vector production is one of the fastest growing products in healthcare for the new generation of cell and gene therapies,” KeyBanc Capital Markets analyst Paul Knight said.

Two years ago, Thermo Fisher bought another contract manufacturer that specialized in making viral vectors, Brammer Bio.

Henogen has about 400 employees and is estimated to have generated revenue of 80 million euros ($97.04 million) in 2020, Thermo Fisher said, adding the business will be part of its pharma services business.

Thermo Fisher has benefited in recent days due to demand for COVID-19 testing, with sales rising 36% to $8.52 billion in the third quarter, helped by a $2 billion boost from the testing.

The Henogen deal was a solid example of how Thermo Fisher is likely to deploy cash flows associated with COVID diagnostics, Evercore ISI analyst Vijay Kumar said.

“Acquiring a strong double-digit top business is extremely compelling in this market.”

https://www.reuters.com/article/us-novasep-hldg-m-a-thermo-fisher/thermo-fisher-buys-henogen-for-nearly-880-million-in-gene-therapy-expansion-idUSKBN29K1BO

Intercept Pharma Cut to Underperform at Bank of America

 Intercept Pharmaceuticals (NASDAQ:ICPT) was downgraded by research analysts at Bank of America from a "neutral" rating to an "underperform" rating in a research report issued on Friday, Briefing.com reports. They presently have a $27.00 target price on the biopharmaceutical company's stock, down from their prior target price of $40.00. Bank of America's price target points to a potential downside of 7.66% from the company's current price.

https://www.marketbeat.com/instant-alerts/nasdaq-icpt-a-buy-or-sell-right-now-2021-01/

JPM: Established relationships were key to pandemic drug launches: Incyte CEO

 COVID-19 lockdowns last year brought challenges for companies in nearly every industry—including pharmaceutical companies trying to get the word out about new drugs. But for companies with established connections, technology served as a suitable temporary substitute to in-person meetings, Incyte CEO Hervé Hoppenot said in an interview. 

After Incyte's original FDA approval for Jakafi in 2011, the company has built up its network of experienced sales reps with connections to doctors and cancer centers. Those connections proved critical during the lockdowns as the company needed to share information about two new cancer drug approvals, Hoppenot said.  

With their prior connections, Incyte’s sales reps were able to call doctors to share “very complicated” information about the new drugs, indications, dosing and how to identify patients. Doctors “would pick up the phone” and were willing to jump on a Zoom meeting to learn more, he said. Those conversations played an important role during the launches for Pemazyre and Monjuvi, both new cancer meds approved in 2020, Hoppenot said. 

For companies without the relationships—or if a sales rep was “coming from the moon” to try and reach a doctor—that's "quite a bit more challenging," Hoppenot said. 

Still, virtual communications aren't the same as visiting a cancer center with a team and meeting everyone involved in a patient's treatment. At some centers, around 15 people—such as nurses and pharmacists—help with cancer care, and it takes a detailed effort to communicate changes in practices, he said. Doing that remotely is “not good.” 

Another part of what the company aims to do is “make sure patients realize it’s more unsafe to not be treated than to go to the cancer center," Hoppenot said.

During coronavirus lockdowns, Medicare billing for cancer patients dropped sharply, which Hoppenot called a "sad story." Many patients haven’t received cancer treatment because of the pandemic, he said. Some missed diagnoses, while others missed treatments.

Pharma companies of various sizes have set out with new drug launches during the pandemic, while some have delayed drug rollouts. The FDA approved 53 new molecular entities last year, meaning companies had to adapt to get out the word about their new medicines. Drugmakers quickly embraced digital marketing efforts and virtual communications, and Fierce Pharma Marketing predicts the trends will continue into 2021 and beyond. 

https://www.fiercepharma.com/pharma/jpm-established-relationships-were-key-to-pandemic-drug-launches-incyte-ceo-says

DBV Updates on Investigational Viaskin™ Peanut for Children Ages 4-11

 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the receipt of written responses from the U.S Food and Drug Administration (FDA) to questions provided in the Type A meeting request the Company submitted in October 2020.  The Type A meeting request was submitted following the Company’s receipt of a Complete Response Letter (CRL) in connection with its Biologics License Application (BLA) for Viaskin™ Peanut (DBV712), an investigational, non-invasive, once-daily epicutaneous patch to treat peanut allergy in children ages 4 to 11 years.

DBV believes that the feedback received from the FDA provides a well-defined regulatory path forward. In exchanges with the FDA, DBV proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. DBV will address details about a new human factor (HF) validation study and additional chemistry, manufacturing and controls (CMC) data in subsequent interactions with the FDA.

The FDA agreed with DBV's position that a modified Viaskin™ Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin™ Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 one peanut) remains unchanged and performs in the same way it has performed previously.

In order to confirm the consistency of efficacy data between the existing and modified patches, FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin™ Peanut patch in the intended patient population.

https://finance.yahoo.com/news/dbv-technologies-provides-investigational-viaskin-213000879.html

Pfizer to temporarily reduce Covid vaccine deliveries to Europe

  Pfizer will temporarily reduce the number of doses of its coronavirus vaccine being delivered to Europe.

The Norwegian Institute of Public Health received a message from Pfizer “little before 10 o’clock” Friday, according to a translation of a statement released by the authority shortly afterwards. NIPH’s statement said that deliveries of the Pfizer-BioNTech vaccine would be reduced from next week “and for a period ahead.”

“We were predicted 43,875 vaccine doses from Pfizer in week 3. Now it seems that we get 36,075 doses,” the statement said.

NIPH said the temporary reduction in deliveries was “in connection with an upgrade of production capacity.” “The temporary reduction will affect all European countries,” it added.

Pfizer later confirmed the disruption to deliveries in a statement. “As part of the normal productivity improvements to increase capacity, we must make modifications to the process and facility that will require additional regulatory approvals,” it explained.

Pfizer added that while this would “temporarily impact shipments in late January to early February, it will provide a significant increase in doses available for patients in late February and March.”  

In the meantime, Pfizer said that there may be “fluctuations in orders and shipping schedules” at its Puurs facility in Belgium “in the immediate future.”

Pfizer CEO Albert Bourla told CNBC’s “Squawk Box” on Tuesday that he felt confident that it could “increase dramatically” production of the vaccine this year with a goal of manufacturing up to 2 billion doses.

Bourla also said Pfizer currently had more doses of its vaccine available than were being used.

The European Union said last week that it was doubling its stock of the Pfizer-BioNTech vaccine.

Ursula von der Leyen, president of the European Commission, said the agreement would allow the EU to purchase another 300 million doses to its existing stock. The EU’s executive arm has already been criticized for not buying more of the vaccine.

Rollouts have been slow across many EU nations, including France, Germany and the Netherlands, and this latest news will likely weigh on inoculation programs in those counties. Canada has also confirmed that its shipments will be delayed, but said it’s hopeful that it won’t impact its vaccination program.

https://www.cnbc.com/2021/01/15/pfizer-to-temporarily-reduce-covid-vaccine-deliveries-to-europe.html

Indivior raises revenue forecast as U.S. opioid treatment sales recover

 Indivior Plc revised its annual revenue forecast higher than earlier on Friday, encouraged by a recovery in U.S. sales of the British drugmaker's opioid addiction treatment in the fourth quarter, sending its shares up by 7.4% in early trade.

The company's Suboxone film, whose cheaper copycat versions have hurt Indivior's sales in the past, has been one of the main treatments for addiction through a growing epidemic of opioid abuse in the United States.

It added that it expected to deliver adjusted pre-tax income ahead of its expectations.

Indivior had said in October that it saw modest improvement in new patient enrollments in the third-quarter, compared to a rapid decline in the prior quarter, due to coronavirus-related disruptions.

Indivior has been embroiled in multiple legal battles over the past years, including a 1.07 billion pound ($1.46 billion) legal claim from former parent Reckitt Benckiser relating to their demerger agreement. It last year agreed to pay $600 million to settle U.S. opioid treatment marketing claims.

The drugmaker said it expected annual revenue to be in the range of $645 million to $650 million, up from its previous guidance range of $595 million to $620 million. In 2019, it reported an annual revenue of $785 million.

Shares of the FTSE-250 drugmaker, which nearly tripled in value last year, was the top percentage gainer on the index after the announcement. 

https://www.marketscreener.com/quote/stock/INDIVIOR-19344116/news/Indivior-raises-revenue-forecast-as-U-S-opioid-treatment-sales-recover-32202425/

India to treat homegrown COVID-19 vaccine same as AstraZeneca's

 

India will treat a domestic COVID-19 vaccine "equally" with a prominent global one, even though the homegrown drug's efficacy has not been proven, and people will have no choice which one they get, a top government vaccine official told Reuters.

The government on Saturday will launch one of the world's biggest vaccination programmes with shots manufactured in India - one developed by Oxford University and AstraZeneca Plc, the other by Bharat Biotech International Ltd with a state-run institute.

Administering Bharat Biotech's COVAXIN, a move cheered by nationalist politicians, has worried some health experts who consider it rushed, as the vaccine has only limited, "clinical-trial mode" approval. In addition to efficacy concerns, the close monitoring required for its use will be a massive challenge in a country of 1.35 billion people.

Controversy over COVAXIN - similar to what China and Russia faced for pushing through their own shots before their efficacy was known - risks undermining India's position as the vaccine capital of the world, medical ethics groups say.

"No vaccine is a backup to the other - both vaccines are equally important, both vaccines are hugely immunogenic," Vinod K. Paul, who heads a government panel on vaccine strategy, said in an interview. They excite immunity against the virus."

"There is no choice to the individual at this point of time" as India ramps up production of the vaccines, he said.

This marks the government's clearest statement that recipients may not choose their vaccine. The health secretary said this week that no other country allows a choice but stopped short of saying India would do the same.

Experts at India's drug regulator this month recommended stricter monitoring for COVAXIN, as is done during clinical trials, especially if cases of infection by mutant strains of the virus spread fast. At the same time, the government wants to inoculate as many people as possible as demand for vaccines outstrips supply.

Indian health advocacy groups, watchdogs and opposition politicians have questioned the local vaccine's approval, which came just a day after the authorities asked Hyderabad-based Bharat Biotech for more evidence it would work.

"This achievement will indeed be hailed as a major Indian scientific achievement once efficacy data are released, but by this hasty approval without evidence, the government has shot itself in the foot," the All India People's Science Network, a network of science advocacy groups, said in a statement.

"Whatever prestige India may gain abroad for an indigenously developed vaccine will be outweighed by the damage caused to the credibility of COVAXIN in particular, and of Indian science, research and regulatory institutions."

Paul defended moving ahead with the drug, which Bharat Biotech developed with the Indian Council of Medical Research, saying all COVID-19 vaccines in the world, including those by Pfizer Inc and Moderna Inc, are administered under emergency authorisation.

"The scientific rigour under the circumstances of the pandemic has been respected in a robust manner," Paul said. "There is no pressure" on India's regulator, the Central Drugs Standard Control Organization. "They take decisions based on science and regulatory norms."

PROUD POLITICIANS, RELUCTANT REGULATORS

Prime Minister Narendra Modi has said every Indian should be proud of the made-in-India COVAXIN, calling its approval a sign of a "self-reliant" country.

Brazil this week became the first foreign country to sign a deal to buy the Indian shot.

India's emphasis on the domestic vaccine comes as the government asks Pfizer and Moderna to make their highly efficacious shots in India for local and global distribution.

Paul said Pfizer would have to do an additional safety and immunogenicity trial in India.

He said it is the responsibility of government officials like himself to answer questions about COVAXIN. All required protocols - such as closer proactive monitoring of recipients for any adverse effects - will be followed, he said.

The government has already bought 11 million doses of the AstraZeneca COVISHIELD shot and 5.5 million of COVAXIN - whose efficacy results from last-stage trials are expected by March.

Paul declined to say whether the government, which wants about 600 million vaccine doses in the next six to eight months, would buy an equal number of doses of both vaccines. Bharat Biotech did not respond to requests for comment.

The drug regulator believes COVAXIN will be more effective on new strains of the coronavirus as it is designed to act against the whole body of a virus, not just its "spike-protein" tip.

Some of its experts, nevertheless, were reluctant to give the emergency nod to COVAXIN for much of the hours-long meetings they had late last month and early this month, said a person with direct knowledge of the deliberations.

Published minutes https://cdsco.gov.in/opencms/opencms/en/Committees/SEC of the meetings also showed that the initial position of the panel - which had wanted to wait for some sort of efficacy data - changed in a matter of days.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Exclusive-India-to-treat-homegrown-COVID-19-vaccine-same-as-AstraZeneca-s-32194950/