Harpoon Therapeutics (HARP) priced 5.4M shares at $14.00, at the midpoint of $13.00-$15.00 range. Citi and SVB Leerink are acting as joint book running managers for the offering.
https://thefly.com/landingPageNews.php?id=2861905
Friday, February 8, 2019
Halozyme Gets $30M from Argenx in Licensing Deal Worth Up to $530M
Argenx, a Dutch firm with a pipeline of investigational antibody-based therapies, will pay San Diego-based Halozyme to use its drug delivery technology to develop subcutaneous versions of some of the drugs Argenx is developing to treat rare autoimmune diseases and cancers.
The technology Halozyme (NASDAQ: HALO) is licensing, called Enhanze, allows drugs that would otherwise be delivered intravenously to be injected, which can turn an hours-long process into one that lasts just minutes.
Argenx (NASDAQ: ARGX) agreed to pay Halozyme $30 million up front for exclusive use of the technology for drugs that target the FcRn receptor. One such drug is Argenx’s lead candidate, efgartigimod (ARGX-113), which it is testing as a treatment for multiple diseases, including myasthenia gravis, a chronic autoimmune disorder that causes muscle weakness that often hampers eye and eyelid movement, facial expression, and swallowing.
It also agreed to pay an additional $10 million apiece for up to two additional targets; and up to $160 million in milestone payments for each target with which it chooses to move forward. Halozyme will also get “mid-single digit royalties” on products that make it to the market.
“We believe that by offering both intravenous and subcutaneous formulations, we have the opportunity to capture patient preferences across all indications within our efgartigimod portfolio,” Argenx Chief Operating Officer Keith Woods said, in prepared remarks. In addition to its Netherlands headquarters, Argenx, headed by co-founder Tim Van Hauwermeiren, has offices in Belgium and in Boston, MA.
The Argenx collaboration is the fifth Enhanze deal Halozyme has inked in the past two years, and the company is the ninth biopharmaceutical with which it has a partnership. Its stock rose 3 percent on the news, from $16.12 a share at market close Friday to $16.62 apiece Monday. Tuesday marked another good trading day for Halyzome, with shares closing at $16.95 each.
The recent licensing deals have brought in a total of $230 million in upfront payments, according to the company.
Halozyme has said that it expects to pull in a total of $1 billion in royalty payments by 2027, although Jeffries & Co. analyst Eun Yang, in a November research note, called that estimate “overly optimistic,” especially in its assumption that all of the original brand drugs would be converted to the Enhanze versions. That’s been the case with fewer than 50 percent of the three Enhanze products that have been marketed to date, according to Yang. The total amount Haloyzme received in royalty payments last year was $85 million, the company said. That’s more than the company shells out annually for operating expenses for Enhanze, according to a presentation that Haloyzme CEO Helen Torley gave at the JP Morgan Healthcare Conference in San Francisco in January.
This year, the company anticipates hitting a number of milestones in partnerships it has previously struck. In addition to Argenx, Swiss pharma giant Roche, Pfizer (NYSE: PFE), Janssen (NYSE: JNJ]]), Baxalta (a subsidiary of Shire, recently acquired by Takeda (NYSE: TAK), AbbVie (NYSE: ABBV), Eli Lilly (NYSE: LLY), Bristol-Myers Squibb (NYSE: BMY), and Boston-based Alexion (NASDAQ: NLXN) are also using Enhanze to develop drugs that can be delivered subcutaneously.
Roche subsidiary Genentech has said it anticipates a response from the FDA in March on its injectable version of the cancer drug trastuzumab (Herceptin), which is already being sold outside of the U.S. Also this year, Janssen anticipates completing its Phase 3 trial of its subcutaneous version of daratumumab (Darzalex), which is used to treat multiple myeloma.
Torley is leading the company through a pivotal time. Separately from its Enhanze business, Halozyme is also trying to become a cancer drug maker. In November, it is slated to reveal top-line data from global Phase 3 trials of its investigational drug pegvorhyaluronidase alfa (PEGPH20), which it is testing in combination with chemotherapy drugs as a treatment for advanced pancreatic cancer.
The drug candidate is based on the company’s patented recombinant human hyaluronidase enzyme (rHuPH20) which underpins its Enhanze technology, too: The enzyme breaks down hyaluronan, a gel-like fluid that’s present under the skin, which can smooth the way for drug dispersion and absorption.
Despite Financial Losses, Seattle Genetics CEO Banks on Assets to Drive Strong 2019
Despite having achieved a record net sales of $477 million driven by the success of its powerhouse medication Adcetris in 2018, as well as a 58 percent increase in sales during the fourth quarter in comparison to the previous year, Seattle Genetics‘ stock fell as the results did not meet analysts’ expectations.
Adcetris, which gained two additional approvals from the U.S. Food and Drug Administration (FDA) this year for previously untreated Stage III or IV classical Hodgkin lymphoma and as a frontline treatment for CD30-expressing peripheral T-cell lymphoma, generated net revenue of $476.9 Million in 2018 in the U.S. and Canada. In the fourth quarter, Adcetris generated $132.1 million, the company said.
Clay Siegall, chief executive officer of Seattle Genetics, said the company expects the momentum for Adcetris will continue through 2019 and will be a primary driver of commercial growth for the company. Siegall said the company anticipates revenue from Adcetris sales in the U.S. and Canada will be between $610 and $640 million, which is an increase of 28 percent to 34 percent over 2018 sales. When looking at global sales, Siegall said Adectris has the potential to hit blockbuster status, sales of more than $1 billion. This year, Adcetris was approved as a frontline treatment for Hodgkin lymphoma in Japan and approval is pending in Europe. According to a transcript of the conference call, Siegall said the company will submit new data to the European Medicines Agency in support of its application for approval later this year.
In addition to Adcetris, Siegall pointed to some coming milestones for the company. It anticipates topline data from a pivotal trial in metastatic urothelial cancer this quarter from enfortumab vedotin (EV), an asset Seattle Genetics is developing with Astellas. Siegall said the data, if it’s positive, could support regulatory submission in 2019 under the FDA’s accelerated approval regulations.
Additionally, later this year, Seattle Genetics is anticipating topline data from its HER2-targeting treatment, tucatinib, an oral tyrosine kinase inhibitor. Siegall said if the HER2ClIMB trial with tucatinib is successful, the company’s intention is to build that drug into a broad development program into earlier lines of breast cancer and other HER2-expressing tumor types.
The company’s third program is tisotumab vedotin or TV, which is being developed in partnership with Genmab. The initial focus of this asset is metastatic cervical cancer. Siegall said the company is conducting an ongoing pivotal trial designed to support a regulatory submission under the FDA’s accelerated approval path. Enrollment in that trial is expected to be complete by the mid-part of this year. Additionally, Siegall said the company is developing TV in other lines of cervical cancer and other solid tumors that express tissue factor.
Over the course of this year, Siegall said the company anticipates submitting Investigational New Drug Applications for additional cancer treatments.
While Siegall was high on the company’s future, Seattle Genetics did report a net loss of $119.8 million for the fourth quarter or 0.75 cents per share. That was in comparison to a net loss of $59.2 million, or $0.41 per share, for the fourth quarter of 2017. For the full year in 2018, net loss was $222.7 million, or $1.41 per share, compared to a net loss of $125.5 million, or $0.88 per share, for the year in 2017. It was this financial point that disappointed analysts. That sent the stock down nearly 10 percent in premarket trading. The more-than-expected losses are continuing to drive share prices down this morning. Since the market opened, shares are down more than 2.5 percent.
Seattle Genetics said the fourth quarter loss includes a net investment loss of $53.2 million primarily associated with Seattle Genetics’ common stock holdings in Immunomedics.
Gossamer Bio indicated to open at $22.40, IPO priced at $16.0
Gossamer Bio indicated to open at $22.40, IPO priced at $16.00 Gossamer Bio (GOSS) priced shares at $16.00. The deal size was upsized from 14.375M shares. BofA/Merrill, SVB Leerink, Barclays and Evercore ISI are acting as joint book running managers for the offering.
https://thefly.com/landingPageNews.php?id=2861877
https://thefly.com/landingPageNews.php?id=2861877
Short seller Carson Block targets medical device company Inogen
Prominent short seller Carson Block is saying that medical device company Inogen Inc has inflated the size of its markets and expects the stock price to fall.
Block, whose research firm Muddy Waters is best known for targeting the shares of China-based companies, has written a new report that asserts that Inogen’s management has made overly optimistic growth forecasts.
Calls to the company’s media relations and investor relations departments seeking comment were not returned.
Muddy Waters is short Inogen Inc because it question’s Inogen’s statements about total addressable market size and potential growth, the report seen by Reuters said.
Inogen makes lightweight portable oxygen concentrators that free its users from being tethered to heavy tanks.
While the company has said the U.S. TAM is roughly 3 million users and is growing at 7 percent to 10 percent a year, Block said the real U.S. TAM is far smaller at about 1.3 million, citing Centers for Medicare & Medicaid Services (CMS) data. He also said CMS data shows that the oxygen therapy market has been shrinking. He wrote that Inogen based its estimates on data from Wintergreen Research.
“The key to INGN’s extreme multiple is its blue sky story,” the report said. The company’s stock had climbed steadily to a high of $282.92 in September but has declined by more than half since then, trading Friday morning at $137.03, down 1.9 percent.
Block sees more room for it to fall, arguing that “INGN will hit peak sales as soon as this year, and likely no later than next.”
Cara Therapeutics Started by Jefferies
Jefferies Financial Group began coverage on shares of Cara Therapeutics (NASDAQ:CARA) in a research note issued on Wednesday, Marketbeat reports. The brokerage set a “buy” rating and a $22.00 price target on the biopharmaceutical company’s stock. Jefferies Financial Group’s target price would indicate a potential upside of 44.45% from the stock’s current price.
Examining aspirin use to prevent colorectal cance
Colorectal cancer is the third most common cause of cancer deaths in the United States and advanced colorectal polyps are a major risk factor. The U.S. Preventive Services Task Force (USPSTF) concluded that aspirin reduces the risk of colorectal cancer by 40 percent as well as recurrence of advanced polyps. Their guidelines suggest that, without a specific contraindication, health care providers should routinely prescribe aspirin to all patients with advanced colorectal polyps.
To explore whether patients are adhering to these USPSTF recommendations and guidelines, researchers from Florida Atlantic University’s Schmidt College of Medicine analyzed data from structured interviews on 84 patients, ages 40 to 91 years old, with biopsy proven advanced colorectal polyps between July 1, 2013 to June 30, 2017.
The data, which were published in the American Journal of Medicine, showed that only 36 (42.9 percent) of the 84 patients with advanced colorectal polyps reported taking aspirin.
“These data indicate underutilization of aspirin to prevent colorectal cancer as well as recurrent polyps in these high risk patients,” said Charles H. Hennekens, M.D., Dr.P.H., senior author, the first Sir Richard Doll Professor, and senior academic advisor in FAU’s Schmidt College of Medicine.
Co-authors include the first author, Benjamin Fiedler, a senior at Cornell University who has been accepted as a first-year medical student at the Schmidt College of Medicine; Lawrence Fiedler, M.D., a gastroenterologist and affiliate associate professor; Michael DeDonno, Ph.D., assistant professor; Kosi Anago, M.D., a former internal medicine resident; Leonie de la Cruz, a former medical student; and George R. Luck, M.D., associate professor, all in FAU’s Schmidt College of Medicine.
“These data pose major challenges that require multifactorial approaches by clinicians and their patients,” said Benjamin Fiedler. “These approaches should include therapeutic lifestyle changes, adjunctive drug therapies as well as screening.”
Therapeutic lifestyle changes of proven benefit include avoiding and treating overweight and obesity as well as regular physical activity and adjunctive drug therapies including aspirin.
“By utilizing these multifactorial approaches, we believe that these efforts should achieve the most good for the most patients concerning the prevention as well as screening and early diagnosis and treatment of colorectal cancers,” said Hennekens, who has done ground-breaking research on the benefits of statins, aspirin, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) as well as beta adrenergic blockers — all of which play major roles in decreasing premature deaths from heart attacks and strokes.
Hennekens was the first to demonstrate that aspirin significantly reduces a first heart attack as well as recurrent heart attacks, strokes, and cardiovascular death when given within 24 hours after onset of symptoms of a heart attack as well as to a wide variety of patients who have survived a blockage in the heart, brain or legs. His landmark and first discoveries on aspirin are not limited to cardiovascular disease and include the prevention of recurrent migraine headaches. He also hypothesized from earlier observational study data that aspirin may decrease risks of colorectal cancer and delay cognitive loss as well as reduce the development of type 2 diabetes. Since then, randomized trials and their meta-analyses have indicated that aspirin prevents colorectal polyps as well as colorectal cancer.
“More than 90 percent of patients diagnosed with colorectal cancer are 50 years or older. The major risk factors are similar to those for heart attacks and stroke and include overweight, obesity as well as physical inactivity, a diet low in fiber and high in fat as well as type 2 diabetes,” said Lawrence Fiedler, M.D.
According to the U.S. Centers for Disease Control and Prevention, additional risk factors include inflammatory bowel disease such as Crohn’s disease or ulcerative colitis; a personal or family history of colorectal cancer or colorectal polyps; and a genetic syndrome such as familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (Lynch syndrome).
Story Source:
Materials provided by Florida Atlantic University. Original written by Gisele Galoustian. Note: Content may be edited for style and length.
Journal Reference:
- Benjamin Fiedler, Lawrence Fiedler, Michael DeDonno, Kosi Anago, Leonie de la Cruz, George R Luck, Charles H. Hennekens. Underutilization of Aspirin in Patients With Advanced Colorectal Polyps. The American Journal of Medicine, 2019; DOI: 10.1016/j.amjmed.2018.12.037
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