The Middletown Press (Middletown, CT)
Arvinas, Pfizer in deal for breast cancer drug
NEW HAVEN — Cancer drug developer Arvinas and pharmaceutical giant Pfizer on Thursday announced a $2.4 billion deal that seeks to advance a breast cancer treatment already in Arvinas’ product pipeline.
Arvinas is retaining full ownership of the drug, but the two companies will evenly split sales revenue from the drug if it is approved for market.
The joint venture effort to develop Arvinas’ drug candidate ARV-471 has two components.
One calls for Pfizer to acquire a 7 percent ownership stake in Arvinas, a biotech based in New Haven’s Science Park, for $350 million. The other involves Arvinas receiving an upfront payment of $650 million along with $400 million as ARV-471 advances through the drug regulatory approval process, and up to $1 billion for certain commercial milestones the drug might achieve were it to make it to market.
“This a landmark event, both for Arvinas and for individuals with breast cancer who are seeking a new treatment,” said Arvinas CEO John Houston. “This collaboration has the potential to be transformational, as it combines our leadership in targeted protein degradation with Pfizer’s global capabilities and deep expertise in breast cancer. We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-inclass therapy.”
Andy Schmeltz, global president and general manager of Pfizer Oncology, said company officials “are very impressed with the science here (at Arvinas).”
“We believe ARV-471 is the next important advance in hormone therapy,” Schmeltz said. “It could provide hope to many people.”
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Kirsten Owens, an Arvinas spokeswoman, said some of the research and development as ARV-471 advances toward a new drug application will be done in Connecticut.
Owens said Arvinas “regularly evaluates our headcount growth and needs based on the execution of our strategic objectives.”
“Given this morning’s announcement, and our goal to potentially commercialize ARV-471, scaling and building Arvinas over the next few years will be critical,” she said.
Ginny Kozlowski, executive director of the Economic Development Corp. of New Haven, said the interest of a company with an international reputation like Pfizer in doing a partnership with Arvinas “speaks to the strength of their science.”
“This is positive news for them,” Kozlowski said. “The plus is that Arvinas is getting to take advantage of Pfizer’s years of experience in the field of breast cancer.”
Owens said Arvinas currently employs about 220 people.
Kozlowski said it is critical to remember that ARV-471 is not the only cancer drug Arvinas is working on that could influence how many new employees the company hires in the future.
“But if this product becomes successful, whatever hiring they do will become exponentially larger,” she said.
Pfizer officials said the market for all types of breast cancer drugs is about $20 billion and is expected to grow to more than $40 billion over the next five to seven years.
Denise Barajas, an associate professor at Quinnipiac University’s Frank H. Netter MD School of Medicine, said about there are about 250,000 new cases of breast cancer among women each year.
The most frequently used class of drugs to treat breast cancer are known as aromatase inhibitors, which stop the production of estrogen in postmenopausal women. The bestknown drug in that class is Tamoxifen, which was approved by the Food and Drug Administration in 1997.
Barajas said that in some cases, aromatase inhibitors initially are effective, but fail to keep working. ARV-471, if approved by the FDA, could help women facing that problem or those who cannot tolerate the side effects of drugs like Tamoxifen, she said.
Phase III trials for ARV-471, the last step in the development process before a drug is submitted to the FDA for approval, are expected to begin sometime in 2022. Owens said the Phase III trials of the drug candidate will be done to assess its effectiveness in treating both metastatic and early breast cancer.
“To pursue this aggressive plan, and with multiple global pivotal trials right around the corner, we think that now is the right time to bring on a strategic partner,” she said. “We envision that the partnership will broaden and accelerate our clinical program by leveraging Pfizer’s deep experience and success in breast cancer, allowing us to bring this advancement to patients sooner.”
Until the company sees the outcome of the Phase III tesing, Owens said company officials aren’t able to estimate when Arvinas will file its new drug application.
Pfizer and Arvinas will share worldwide development costs, commercialization expenses and profits, she said.
“The proceeds to Arvinas from Pfizer will offset Arvinas’ development costs for ARV-471 and also support Arvinas’ continued investment in its preclinical programs and platform,” Owens said,
Arvinas officials view ARV-471 as a drug with the potential to “build a company around,” she said.
“Keep in mind that Arvinas will be progressing ARV-110 simultaneously (for treatment of prostate cancer),” Owens said. “We expect to build the development and commercial infrastructure to support multiple programs across oncology, neuroscience and other therapeutic areas.”
Arvinas’ joint venture with Pfizer culminates a period in which a number of companies have “had interest” in partnering with the company, she said.
“Pfizer is the right partner for this collaboration due to their global oncology capabilities, infrastructure, and expertise, in addition to their commitment to patients with breast cancer,” Owens said.
Arvinas’ stock trades on the Nasdaq Exchange under the ticker symbol ARVN. The stock price was $84.51 at the close of trading on U.S. financial markets Thursday, an increase of $6.96 over Wednesday’s closing number.
Arvinas is one of the Connecticut biotech cluster’s most promising companies. The company will anchor a new biotech research and office complex currently under construction at 101 College St.