Aug 13 U.S. biotechnology company Genzyme Corp
GENZ.O, a maker of extremely expensive lifesaving medicines
for rare genetic disorders, is considering an acquisition offer
by French drugmaker Sanofi-Aventis (SASY.PA).
A key focus of any talks will be Genzyme's ability to move
past a viral contamination at its main plant that caused severe
shortages of its most important products. [ID:nN12260234]
The manufacturing crisis has punished Genzyme's earnings
and share price and made it more vulnerable to dissident
investors. Analysts say it may also strengthen Sanofi's case
that a deal price reflect the risk in fixing those problems.
The following is a timeline of significant developments:
March 2 - Company discloses FDA warning letter identifying
manufacturing deficiencies at Allston, Massachusetts plant.
June 16 - Discloses viral contamination leading to shutdown
and severe shortages of key drugs Cerezyme and Fabrazyme.
July 16 - Due to Cerezyme shortage, Shire (SHP.L) gets FDA
fast track designation for experimental Gaucher treatment.
July 31 - FDA says will reinspect Allston after company
fails to take sufficient action on process control problems.
Aug. 14 - Only those in most need get Cerezyme in Europe.
Aug. 25 - FDA grants fast track review to Protalix
BioTherapeutics (PLX.A) experimental Gaucher disease drug to
help address shortage; Pfizer (PFE.N) later acquires rights.
Nov. 13 - FDA says five drugs made at Allston have
unacceptable levels of steel fragments, other contaminants.
Dec. 1 - Newly made Cerezyme begins shipping from Allston.
Jan. 4 - Genzyme announces deal for Hospira Inc HSP.N to
take on some filling and packaging for several products.
Jan. 7 - Genzyme agrees to appoint activist investor Ralph
Whitworth of Relational Investors to board; reports surface
that billionaire investor Carl Icahn may mount a proxy battle.
Jan. 8 - Ron Branning appointed to head global quality.
Jan. 12 - Newly made Fabrazyme beings shipping.
Feb. 3 - Company appoints former Eli Lilly (LLY.N)
executive Scott Canute as global manufacturing chief.
Feb. 22 - Company receives notice that Icahn intends to
nominate four candidates to board.
Feb. 26 - FDA approves Shire Gaucher disease drug.
March 24 - Genzyme says FDA to take enforcement action,
likely including imposing fines, over manufacturing crisis.
April 15 - Whitworth joins board in move to rebuff Icahn.
April 21 - Genzyme says expects to pay $175 million penalty
from past profits and possibly future fines under draft consent
decree deal; discloses a March power outage affecting water at
Allston, worsening Cerezyme and Fabrazyme supply shortage.
May 6 - Under pressure from investors Genzyme says will
look into selling three non-core businesses -- genetic testing,
diagnostic products and pharmaceutical materials.
May 17 - Icahn doubles stake to about 10.5 million shares.
May 24 - Consent decree finalized. In addition to $175
million penalty, company to move filling and packaging out of
Allston, place manufacturing under oversight of a third party.
May 26 - Icahn urges board to remove CEO Henri Termeer.
June 9 - Icahn reaches accord with Genzyme, abandons proxy
fight and gets two representatives on board.
June 29 - Still struggling with supply shortages, Genzyme
says expects to meet 50 percent of Cerezyme demand for July.
July 21 - Genzyme takes $21.9 million write-off in second
quarter due to products discarded over quality issues.
July 23 - Sources tell Reuters that French drugmaker
Sanofi-Aventis made acquisition approach to Genzyme.
July 28 - Sanofi votes to move ahead with formal offer of
up to $18.7 billion to acquire Genzyme, sources say.
Aug. 2 - Sanofi sends $69/share takeover proposal to
Genzyme, sides discussing offer, sources say.
Aug. 9 - Company discloses additional $6.5 million
write-off for discarded products due to quality issues that
turn second quarter results from flat to a loss.
Aug. 10 - Company says it will take three to four years to
rectify manufacturing problems at Allston.
Nov. 28, 2010 - Genzyme must finish transition of filling
and finishing of products intended for U.S. from Allston; to be
done in Genzyme plant in Ireland, Hospira plant in Kansas.
Aug. 31, 2011 - Filling and finishing of products intended
for sale outside U.S. must transfer from Allston; While bulk of
Cerezyme, Fabrazyme manufacturing will continue in Allston,
filling and packaging will cease there.
Late 2011: Genzyme anticipates FDA approval of new plant in
Framingham, Massachusetts that will expand manufacturing
capacity for Fabrazyme and later Cerezyme.
(Compiled by Bill Berkrot. Editing by Michele Gershberg)