Will Competitors’ Patent Expiration Help Pfizer XALKORI Lead the Segment? – Business Finance News

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Pfizer Inc. (NYSE:PFE) announced that the US Food and Drug Administration (FDA) has given an approval for its supplemental New Drug Application (NDA) for XALKORI (crizotinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) patients having ROS1-positive tumors.

In 2015, the drug was granted a Breakthrough Therapy (BT) and Priority Review designation for the aforementioned indication. XALKORI is also indicated for patients with metastatic NSCLC associated with tumors that are anaplastic lymphoma kinase (ALK)-positive as identified by an FDA-approved test.

The drug is the first one in its category (ALK inhibitor),which is approved in the US and to date has been used by more than 8,000 patients. The drug carries a price tag of $14,336 per month, or about $172,000 per year. Approximately 188,000 of the 221,000 lung cancer cases diagnosed each year are non-small cell lung cancer.

XALKORI is under European Medicines Agency’s (EMA) review for extension of its marketing into the segments of adult patients with ROS1-positive advanced NSCLC. The European Commission also upgraded the status of the drug from second-line to first line of therapy for the patients suffering from NSCLC.


The ROS1 rearrangements take place when its gene adheres to another gene and alters its normal physiology. This alteration plays a vital role in the development of cancer.

The ratio of the ROS1 rearrangements is observed in approximately 1% of NSCLC cases. Every year, 15,000 patients suffer by oncogenic ROS1 fusions globally.

Till date, no test has been approved by the FDA for the detection of the ROS1 rearrangements in NSCLC patients. Other diagnostic lab tests are developed for the same purpose. Multiple tests are under development for detection of ROS1-positive metastatic NSCLC.


The approval is based on a study, which is a multicenter, single-arm Phase 1 (Study 1001) with the enrollment of 50 patients suffering from ROS1-positive metastatic NSCLC. The patients were treated with an oral administration of 250 mg of XALKORI twice daily. The drug meets the primary endpoints during the study.

Pfizer Oncology senior vice president of Clinical Development and Medical Affairs Dr. Mace Rothenberg said: “Today’s approval of XALKORI for ROS1-positive metastatic NSCLC represents an important milestone for patients who previously had limited treatment options.”

He added: “As the only FDA-approved biomarker-driven therapy that includes two distinct molecular targets in metastatic NSCLC, ROS1 and ALK, XALKORI exemplifies our commitment to precision drug development and to identifying the right treatment for the right patient.”


In April 2015, Pfizer and Merck KGaA had finalized a deal for the in-depth collaboration and co-promotion of the Xalkori indicated for the treatment of NSCLC.

As per the agreement, Merck KGaA will be eligible for Xalkori promotion-related reimbursement in 2015. In 2016, Pfizer will get 80% share in the profit whereas Merck will get a 20% sales based profit. The deal is extended until December 31, 2020, for promotion in Japan, Germany, Canada, France, Spain, Italy, the UK, and the US. China and Turkey will be covered during January 1, 2016, and December 31, 2021.


The company is working religiously on the research and development of different novel molecules for the treatment of cardiovascular, inflammation, neuroscience, pain, and rare diseases.

The drug maker is also emphasizing on the development of biosimilar segment (oncology and auto-immune disorders). This segment is expected to touch $20 billion by 2020. Till date, the drug maker has five biosimilars in the drug pipeline in different phases for the treatment of metastatic breast cancer, follicular lymphoma, and rheumatoid arthritis (RA).


The immunotherapy market has become very competitive as multiple new drugs are soon to be launched or are already present along with a threat of generics and biosimilars. The latest addition is of Opidivo that costs around $14,533 per month almost equal to that of XALKORI. The drug has been approved in three separate entities. It is also approved in combination with previously-accepted Yervoy (ipilimumab).

According to the analysts, Opdivo will touch $2.15 billion in 2016 and is expected to generate a sale of $5.27 billion by 2018.

The other major competitor is Alimta marketed by Eli Lilly. In 2014, the drug has clinched a sale of $2.79 billion. The drug is expected to generate revenue of more than $2 billion by 2021.

Another addition to the NSCLC therapeutic market is Keytruda, marketed by Merck & Co.’s (MRK) Immuno-Oncology franchise. The drug was launched in the fourth quarter of 2014 (4QFY14). In 2015, the drug generated a sale of $566 million.

In such fierce competition, Xalkori is an emerging candidate with an expected sale of $550 million in 2016. In 2015, the drug generated revenue of $488 million and its sale is increasing day-by-day. It is expected that in the near future, the drug will be a threat to the market leaders such as Alimta, Tarceva, as well as Iressa.


XALKORI is going through a very productive time. The drug has time to step up in multiple conditions of NSCLC as the patents of multiple blockbusters are going to expire in near future. In the US, XALKORI’s patent will expire in Nov 2029, and inside Japan in 2032. The leading blockbusters patent – Alimta, is near its expiration in the US, Tarceva patent will be expired in 2018 as well as Iressa’s patent will expire in May 2017.


The therapeutic market of NSCLC is expected to increase across the leading eight developed nations from $5.1 billion in 2013 to $7.9 billion in 2020 with a Compound Annual Growth Rate (CAGR) of 6.6%.

The main factors for the growth will be a launch of new novel molecules as well as biosimilars.

According to the GBI, Pfizer will launch two first-line treatments for squamous cell patients during next four years, namely necitumumab, which is due to launch in early 2016, and Yervoy (ipilimumab) in 2017.

Jefferies Group rated Pfizer stock a Buy and downgraded the target price from $45.00 to $42.00. Zacks Investment Research upgraded the rating from a Hold to a Buy with a $35.00 target price.

Out of 22 analysts, 14 allocated a Buy, six analysts have given a Hold rating, while two have issued a Strong Buy rating for the company stock. Overall, the company has an average Buy rating with a consensus target price of $37.13.

Will Competitors’ Patent Expiration Help Pfizer XALKORI Lead the Segment? – Business Finance News