Market Place
Pipeline Prospector June 2022: Strong industry fundamentals bring gains for biotech indices
It’s been a lackluster year for pharma stocks. Barring March, all other months until May saw bearish trends. But in June, biotech indices began to look up once again. The Nasdaq Biotechnology Index (NBI) rose by 2 percent to US$ 3,748. In May, it had dropped by 3 percent.
The S&P Biotechnology Select Industry Index (SPSIBI) rose by 10 percent to US$ 5,771. The SPDR S&P Biotech ETF (XBI) rose by 11 percent in June. In May, XBI had dropped 10 percent due to inflation-related concerns and the threat of weaker growth.
The month saw M&A rumors and some key drug approvals that indicate strong fundamentals for the biotech sector. However, investors all over the world remain concerned about inflation, rising interest rates and supply chain disruptions.
Access the Pipeline Prospector Dashboard for June 2022 Newsmakers
Seagen’s stock jumps 31 percent on buyout talks; drugs from AbbVie, Lilly gain FDA nods
The biggest buzz in the pharma world is Merck’s interest in buying Seagen for around US$ 40 billion. The news, first published in The Wall Street Journal, sent the stocks of Seagen rising sharply by 31 percent. According to reports, the two pharmas plan to seal the deal around July 28.
AbbVie made modest gains of 4 percent on the stock market as the US Food and Drug Administration (FDA) approved its blockbuster drug Skyrizi (risankizumab-rzaa) as a treatment for adults with moderate-to-severe Crohn’s disease. This was the third nod for the monoclonal antibody. AbbVie is trying to expand the indications for two of its drugs – Rinvoq and Skyrizi – before its blockbuster drug Humira loses market exclusivity.
The other mega cap gainer was Eli Lilly, which saw a string of positive developments. First, Eli Lilly’s key immunology blockbuster Olumiant (baricitinib) bagged FDA approval as the first-ever systemic treatment for alopecia areata, an autoimmune disorder that triggers sudden hair loss. Second, its experimental drug lebrikizumab achieved strong phase 3 results in atopic dermatitis. Lilly intends to file a regulatory application for this drug later this year. And third, Lilly announced a modified purchase agreement with the US government to supply an additional 150,000 doses of its Covid-19 treatment, bebtelovimab, for approximately US$ 275 million.
Bristol Myers Squibb (BMS) was another company that posted a string of positive news, including its acquisition of Turning Point and the expansion of its existing collaboration with Immatics. BMS’ CAR-T therapy Breyanzi (lisocabtagene maraleucel) picked up a second approval in the US. The drug is now approved for treatment of adult patients with newly relapsed or refractory large B-cell lymphoma (LBCL), an aggressive form of blood cancer.
BMS faced some setbacks too — a late-stage study of two rheumatoid arthritis drugs from BMS and Johnson & Johnson failed to meet the main goal of speeding up recovery when compared with a placebo. The drugs, however, did show a significant drop in deaths among hospitalized Covid-19 patients. BMS also withdrew a supplemental biologics license application (sBLA) for Reblozyl for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia as it could not appropriately address the FDA’s questions about its benefit-risk profile in this patient population based on trial data.
Access the Pipeline Prospector Dashboard for June 2022 Newsmakers
Biogen launches Lucentis copycat, BeiGene’s tislelizumab bags ninth nod in China
Biogen’s stock moved up 4.5 percent on news that it is commencing marketing activities of Byooviz, a copycat referencing Roche and Novartis’ blockbuster eye drug Lucentis. Byooviz has a list price of US$ 1,130 per single-use vial, which is 40 percent lower than the price of Lucentis. The drug has been available in the market since July 1.
There was also news that Sage and Biogen’s drug zuranolone had met the main goal in a phase 3 postpartum depression study. The two companies had teamed up in 2020 for zuranolone. Biogen also entered into a collaboration agreement with Alectos to develop and commercialize the latter’s pre-clinical oral Parkinson’s disease med — AL01811. After the disappointing rollout of Aduhelm (aducanumab), Biogen has hopes from this collaboration. Last month, Biogen also withdrew its Canadian drug application for Aduhelm.
China’s National Medical Products Administration (NMPA) has approved BeiGene’s anti-PD-1 antibody tislelizumab in combination with chemotherapy for recurrent or metastatic nasopharyngeal cancer. Tislelizumab is now approved in nine indications in China. NMPA is also evaluating tislelizumab to treat metastatic gastric junction adenocarcinoma in conjunction with chemotherapy. If approved, this will be the tenth indication for tislelizumab in China. Meanwhile, the FDA has deferred action on a BLA for tislelizumab for esophagus cancer until required inspections are completed.
Novartis, which has licensing rights to the drug in North America, Europe and Japan, recently announced results from a late-stage study on the drug when used in combination with chemotherapy. The combo significantly enhanced overall survival as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Amongst small cap gainers were Mirati Therapeutics, Day One Biopharmaceuticals and Amylyx Pharma. Mirati’s stock gained 73 percent on positive findings from an early-stage clinical trial of adagrasib, a treatment for patients with lung cancer harboring the KRAS mutation. The drug is expected to be approved in the US by the year-end. Similarly, Day One’s stock gained 186 percent post positive results from a phase 2 study on its pediatric brain cancer treatment — tovorafenib.
Amylyx’s shares jumped 122 percent last month after the pharma’s amyotrophic lateral sclerosis (ALS) drug – AMX0035 – was approved in Canada. In the US, the biotech will get a second chance to persuade FDA advisers that its ALS drug is effective, as the FDA has decided to reconvene another meeting to discuss the biotech’s application for AMX0035. The meeting will take place on September 7. Back in March, a panel of external advisers to the FDA had narrowly voted against the drug.
Access the Pipeline Prospector Dashboard for June 2022 Newsmakers
Novartis’ MS drug to face generics; Roche’s immunotherapy fails lung cancer trials
Novartis’ stock made big losses after news that cheaper generic versions of its blockbuster multiple sclerosis (MS) drug Gilenya may hit the US market soon, since an appeals court ruled that a patent associated with the drug is invalid. However, Novartis has said it will file a petition to seek further review of this decision.
The Swiss pharma also said it could cut as many as 8,000 staff in a bid to make the organization leaner and save around US$ 1 billion in costs.
In positive
news, an oral drug combination from Novartis has significantly improved the condition of
patients suffering from a common childhood brain cancer. Novartis also received positive
recommendation from the European Medicines Agency (EMA) for the authorization
of Scemblix, a novel treatment for adult patients with
chronic myeloid leukemia.
Sanofi’s stocks saw bearish trend throughout the month. The stocks tumbled 6 percent at the end of the month after the FDA put a partial hold on phase 3 studies of Sanofi’s oral drug — tolebrutinib — in MS and myasthenia gravis following reports of drug-induced liver injury in patients. In positive news, data from a late-stage study on Sanofi and GSK’s experimental Covid-19 vaccine showed it offered protection against the Omicron variant of the coronavirus. The companies plan to submit the new data to regulatory authorities and make the shot available later this year.
Sanofi and Regeneron’s blockbuster drug Dupixent (dupilumab) bagged an FDA approval to treat eczema in young children. With this approval, Dupixent has become the first and only biologic medicine to treat moderate-to-severe eczema in young children.
Roche suffered a setback as its ‘breakthrough’ cancer immunotherapy failed to slow progression of lung cancer in multiple trials. Its experimental Alzheimer’s candidate crenezumab also failed to meaningfully slow or prevent cognitive decline in people at risk of a rare, inherited form of the disease. In positive news, the European Commission granted conditional authorization to Roche’s Lunsumio (mosunetuzumab) to treat adult patients with relapsed or refractory follicular lymphoma who have received at least two prior therapies. This month, FDA accepted its BLA for Lunsumio.
Amgen’s stock fell 5 percent in June. Mirati announced its KRAS inhibitor adagrasib has an objective response rate of 43 percent in non-small cell lung cancer as compared to 37 percent for Amgen’s already approved med Lumakras. An antitrust lawsuit filed by Regeneron that said the former is employing an “illegal, anticompetitive bundling scheme,” to compel payers to use cholesterol drug Repatha to receive rebates for must-have blockbuster drugs. Regeneron maintains that Amgen has made it “economically unfeasible” to continue selling its drug Praluent. In positive news, the FDA approved Amgen’s Riabni, a biosimilar to Roche’s Rituxan, to treat adults living with moderate-to-severe rheumatoid arthritis.
A phase 3 study on Gilead’s cancer drug Trodelvy in HR-positive/HER2-negative breast cancer revealed that it did not significantly extend study participants’ lives compared to chemo. Meanwhile, a late-stage study on Trodelvy’s competitor, AstraZeneca and Daiichi’s Enhertu, has showed that the drug extended survival by over six months in patients with a form of advanced breast cancer.
In positive news for Gilead, the European Commission has approved its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for a third indication. Yescarta has been approved for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
Two small cap companies, Acadia Pharmaceuticals and Athira — saw their stocks tumble as their Alzheimer’s related drugs failed to show benefits.
Access the Pipeline Prospector Dashboard for June 2022 Newsmakers
BMS acquires Turning Point; Regeneron buys rights to Sanofi’s cancer drug Libtayo
June wasn’t a big month for M&As. Barring BMS’ acquisition of Turning Point Therapeutics for an upfront cash amount of US$ 4.1 billion, there weren’t any other big acquisitions.
With the buyout of Turning Point, BMS will have access to the California-based drugmaker’s star candidate — repotrectinib — that targets mutations in certain proteins in the body. The mid-stage drug candidate is undergoing trials to treat non-small cell lung cancer (NSCLC) along with other advanced solid tumors. BMS expects repotrectinib to be approved in the US in 2023.
BMS has also expanded its research partnership with biotech Immatics. As part of the revised deal, the two pharmas will develop two allogeneic off-the-shelf T cell receptor-based therapy (TCR-T) and/or chimeric antigen receptor T (CAR-T) programs owned by BMS. Both companies have the option to develop four additional programs each. The expanded deal has raised the total partnership to US$ 4.2 billion.
Regeneron has bought the global license rights to cancer drug Libtayo (cemiplimab) from Sanofi for an upfront payment of US$ 900 million. As part of the deal, Sanofi will receive a royalty of 11 percent on worldwide net sales of Libtayo. And Roche and Canadian oncology company Repare Therapeutics entered into a US$ 1.3 billion collaboration to develop and commercialize camonsertib, an experimental drug targeted at treating cancer tumors.
Access the Pipeline Prospector Dashboard for June 2022 Newsmakers
Our view
After six months of stock market rout, it’s difficult to say whether the biotech sector is out of the woods. Even though the NBI rose in June, year-to-date performance of NBI is down 20 percent.
While most analysts maintain that the overall investor mood continues to be reserved and bearish, given the macro-economic worries, others are a little more upbeat about the future. Clinical trial results, more M&As, collaborations and investments by biotech companies could change the investor mood. Positive news from the sector could definitely swing the markets in its favor.
Access the Pipeline Prospector Dashboard for June 2022 Newsmakers
Pharma & Biotech Newsmakers in June 2022
| Company | Country | Currency | Market Cap (Bn) | Change In Market Cap (M) | Stock Price | Change In Price |
|---|
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : Pharma & Biotech Recap by PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
