Pfizer Advances PCSK9 Drug Pipeline and Roche Focuses on Personalized Medicine at 33rd J.P. Morgan Healthcare Conference

From January 12 to 15, 2015, the 33rd Annual J.P. Morgan Healthcare Conference was held in San Francisco, USA. As in previous years, major companies dispatched high-profile delegations to announce their prior-year financial performance and unveil their latest products, and this year was no exception. Below, let us follow VCBeat to explore which major biopharmaceutical companies were worth watching in 2015:

Pfizer: Launch of PCSK9 Drug Development

At the conference, Mikael Dolsten, Chief Scientific Officer at Pfizer, stated that in addition to bococizumab, an investigational cholesterol-lowering antibody, the company will also initiate the development of a PCSK9 vaccine this year. Human trials are expected to begin in 2016, and if successful, the vaccine would require only one injection per year. Furthermore, Dr. Dolsten noted that Pfizer’s investigational small-molecule PCSK9 inhibitor pill has demonstrated promising lipid-lowering efficacy in animal studies, with human trials anticipated to commence later this year.

PCSK9 inhibitors lower LDL-C (low-density lipoprotein cholesterol) by inhibiting the PCSK9 enzyme. In addition to Pfizer, Amgen, Sanofi, and Regeneron are also at the forefront of PCSK9 inhibitor development.

Illumina: Latest Product Launch, Focused on Strengthening the Technology Platform

At this opening ceremony, Illumina announced its financial results, reporting a 31% year-over-year growth, and launched four latest sequencing products: the HiSeq X Five system, HiSeq 3000, HiSeq 4000, and NextSeq 550.

Illumina officially states that the HiSeq X Five is dedicated to large-scale human whole-genome sequencing. The HiSeq X Five system consists of five HiSeq X instruments and can be upgraded to the HiSeq X Ten, thereby enabling $1,000 human whole-genome sequencing. Building on the reliable HiSeq 2500 platform, the HiSeq 3000 and HiSeq 4000 utilize innovative patterned flow cell technology to deliver unparalleled sequencing speed and performance. The NextSeq 550 adds array scanning capabilities to the existing high-throughput NextSeq 500 sequencing platform. This system builds a new bridge for users transitioning from array-based applications to sequencing technology platforms.

Furthermore, Illumina announced its exit from the clinical retail business in areas such as NIPT and oncology testing, choosing to focus on optimizing its technology platform and adopting a strategy of establishing partnerships with other companies.

Johnson & Johnson (J&J): Joining the Wave of Divestitures

For the past few years, Johnson & Johnson has quietly watched as other major pharmaceutical peers divested assets, but now it too is joining the ranks of those pursuing spin-offs.

“We believe that both the areas we intend to enter and those we choose not to pursue require thorough consideration,” said Alex Gorsky, CEO of Johnson & Johnson, at the event. “Therefore, if we are not ranked first or second in a specific sector, or if we do not see a clear path to achieving such a position, it may be better to hand over that business to others.” He also pointed out the option of choosing “reshaping” rather than “exiting” within the space—similar to how Novartis (NVS) and GlaxoSmithKline (GSK) joined forces to establish a joint venture to expand their consumer health businesses.

“In 2015, we will strengthen acquisitions in strategic business areas, while our transaction strategy also includes divesting non-core businesses and products that no longer hold a market-leading position.”

On the 12th, Johnson & Johnson and AC Immune reached an agreement to jointly develop a vaccine for Alzheimer’s disease. Previously, Johnson & Johnson and Pfizer had collaborated to develop bapineuzumab, a therapeutic drug for Alzheimer’s disease, but the clinical trials failed.

GlaxoSmithKline (GSK): New Drug Replaces Advair

Last year, GlaxoSmithKline launched two new drugs, Breo and Anoro, intending to replace Advair, whose patent had long expired. However, sales of the two new drugs fell short of expectations. Compounding this issue, the FDA issued guidance on generic versions of respiratory disease medications, providing a streamlined pathway for companies such as Teva and Sandoz to develop generic alternatives to Advair.

As of 2015, there is no need to tell this British pharmaceutical company what it needs to do. Advair is expected to be “a persistent headwind,” with its U.S. sales declining by 20% to 25%. David Redfern, Chief Strategy Officer, stated late in the afternoon on the 13th, “This year, we must make significant progress in shifting our business toward a broader portfolio.” This will involve leveraging new product combinations covered by Medicare Part D prescription drug plans; currently, Breo boasts 76% coverage, and Anoro 65%.

“Compared with 2014, we are in a better position this year,” said Redfern. “Obviously, one of our major challenges this year is to leverage the transition to achieve genuine script adoption and real business growth, as well as build momentum behind the brand.”

Bristol Myers Squibb (BMS) and Merck: A Series of “Encounters”

In September and December 2014, Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo, as PD-1 inhibitors for the treatment of melanoma, received FDA approval.

At the conference, BMS announced the latest updates, revealing highly positive data for Opdivo in the treatment of lung cancer. In a clinical study involving 272 patients with lung cancer, researchers compared the efficacy of Opdivo with that of docetaxel, the standard therapy. The results demonstrated a significant survival advantage for patients receiving Opdivo, meeting the primary endpoint anticipated by the researchers.

The clinical trial results from BMS have made Opdivo the first PD-1 inhibitor to demonstrate efficacy in lung cancer. BMS disclosed that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European regulatory authorities for the approval of Opdivo in the treatment of lung cancer. During the conference, Merck also announced its plan to submit an application to the FDA in mid-2015 for the approval of Keytruda for the treatment of patients with non-small cell lung cancer (NSCLC).

Roche: Continuing Its M&A Path, Focusing on Personalized Medicine

A review of mergers and acquisitions (M&A) in the biopharmaceutical sector in 2014 reveals nine deals valued at over RMB 10 billion each. Amidst the wave of large-scale acquisitions that swept through the industry that year, the Swiss pharmaceutical giant Roche consistently adhered to its own strategy—steering clear of mega-deals and focusing instead on smaller acquisitions and partnerships.

“This year, 2015, Roche will continue along this path, planning more small-scale mergers and acquisitions,” said its Chief Financial Officer, Hippe. In addition, in his report at the conference, Hippe pointed out that Roche would achieve innovation and value creation in the new year and take the lead in personalized medicine.

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